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U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997

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Database Updated 09/15/2014

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
BSI HEALTHCARE
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
DEKRA CERTIFICATION B.V.
NIOM - NORDIC INSTITUTE OF DENTAL MATERIALS
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25TH STREET, NW
BUFFALO MN 55313    
Contact: MARK JOB
Phone: 763 6824139
Fax: 763 6824420
Internet:
http://www.markjob.com
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.1040 Powered algesimeter. II
  868.1075 Argon gas analyzer. II
  868.1150 Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. II
  868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. II
  868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer. II
  868.1400 Carbon dioxide gas analyzer. II
  868.1430 Carbon monoxide gas analyzer. II
  868.1500 Enflurane gas analyzer. II
  868.1620 Halothane gas analyzer. II
  868.1640 Helium gas analyzer. II
  868.1670 Neon gas analyzer. II
  868.1690 Nitrogen gas analyzer. II
  868.1700 Nitrous oxide gas analyzer. II
  868.1720 Oxygen gas analyzer. II
  868.1730 Oxygen uptake computer. II
  868.1750 Pressure plethysmograph. II
  868.1760 Volume plethysmograph. II
  868.1780 Inspiratory airway pressure meter. II
  868.1800 Rhinoanemometer. II
  868.1840 Diagnostic spirometer. II
  868.1850 Monitoring spirometer. II
  868.1860 Peak-flow meter for spirometry. II
  868.1880 Pulmonary-function data calculator. II
  868.1890 Predictive pulmonary-function value calculator. II
  868.1900 Diagnostic pulmonary-function interpretation calculator. II
  868.1920 Esophageal stethoscope with electrical conductors. II
  868.2025 Ultrasonic air embolism monitor. II
  868.2375 Breathing frequency monitor. II
  868.2385 Nitrogen dioxide analyzer. II
  868.2500 Cutaneous oxygen (PcO2) monitor. II
  868.2600 Airway pressure monitor. II
  868.2775 Electrical peripheral nerve stimulator. II
  868.5090 Emergency airway needle. II
  868.5120 Anesthesia conduction catheter. II
  868.5130 Anesthesia conduction filter. II
  868.5140 Anesthesia conduction kit. II
  868.5150 Anesthesia conduction needle. II
  868.5160 Gas machine for anesthesia or analgesia. II
  868.5170 Laryngotracheal topical anesthesia applicator. II
  868.5250 Breathing circuit circulator. II
  868.5260 Breathing circuit bacterial filter. II
  868.5270 Breathing system heater. II
  868.5330 Breathing gas mixer. II
  868.5430 Gas-scavenging apparatus. II
  868.5440 Portable oxygen generator. II
  868.5470 Hyperbaric chamber. II
  868.5630 Nebulizer. II
  868.5655 Portable liquid oxygen unit. II
  868.5665 Powered percussor. II
  868.5690 Incentive spirometer. II
  868.5710 Electrically powered oxygen tent. II
  868.5730 Tracheal tube. II
  868.5750 Inflatable tracheal tube cuff. II
  868.5800 Tracheostomy tube and tube cuff. II
  868.5870 Nonrebreathing valve. II
  868.5880 Anesthetic vaporizer. II
  868.5895 Continuous ventilator. II
  868.5905 Noncontinuous ventilator (IPPB). II
  868.5915 Manual emergency ventilator. II
  868.5925 Powered emergency ventilator. II
  868.5935 External negative pressure ventilator. II
  868.5965 Positive end expiratory pressure breathing attachment. II
  868.6250 Portable air compressor. II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1020 Acid phosphatase (total or prostatic) test system. II
  862.1025 Adrenocorticotropic hormone (ACTH) test system. II
  862.1035 Albumin test system. II
  862.1045 Aldosterone test system. II
  862.1050 Alkaline phosphatase or isoenzymes test system. II
  862.1065 Ammonia test system. I
  862.1070 Amylase test system. II
  862.1085 Angiotensin I and renin test system. II
  862.1090 Angiotensin converting enzyme (A.C.E.) test system. II
  862.1100 Aspartate amino transferase (AST/SGOT) test system. II
  862.1110 Bilirubin (total or direct) test system. II
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  862.1118 Biotinidase test system. II
  862.1120 Blood gases (PCO2, PO2) and blood pH test system. II
  862.1140 Calcitonin test system. II
  862.1145 Calcium test system. II
  862.1150 Calibrator. II
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1160 Bicarbonate/carbon dioxide test system. II
  862.1170 Chloride test system. II
  862.1177 Cholylglycine test system. II
  862.1187 Conjugated sulfolithocholic acid (SLCG) test system. II
  862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. II
  862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. II
  862.1225 Creatinine test system. II
  862.1230 Cyclic AMP test system. II
  862.1295 Folic acid test system. II
  862.1310 Galactose test system. I
  862.1315 Galactose-1-phosphate uridyl transferase test system. II
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1377 Urinary homocystine (nonquantitative) test system. II
  862.1410 Iron (non-heme) test system. I
  862.1415 Iron-binding capacity test system. I
  862.1445 Lactate dehydrogenase isoenzymes test system. II
  862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. II
  862.1495 Magnesium test system. I
  862.1509 Methylmalonic acid (nonquantitative) test system. II
  862.1545 Parathyroid hormone test system. II
  862.1555 Phenylalanine test system. II
  862.1580 Phosphorus (inorganic) test system. I
  862.1585 Human placental lactogen test system. II
  862.1600 Potassium test system. II
  862.1660 Quality control material (assayed and unassayed). I
  862.1665 Sodium test system. II
  862.1675 Blood specimen collection device. II
  862.1680 Testosterone test system. I
  862.1685 Thyroxine-binding globulin test system. II
  862.1690 Thyroid stimulating hormone test system. II
  862.1695 Free thyroxine test system. II
  862.1700 Total thyroxine test system. II
  862.1730 Free tyrosine test system. I
  862.1770 Urea nitrogen test system. II
  862.1775 Uric acid test system. I
  862.1810 Vitamin B12 test system. II
  862.1825 Vitamin D test system. II
  862.2250 Gas liquid chromatography system for clinical use. I
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1100 Blood pressure alarm. II
  870.1110 Blood pressure computer. II
  870.1120 Blood pressure cuff. II
  870.1130 Noninvasive blood pressure measurement system. II
  870.1140 Venous blood pressure manometer. II
  870.1200 Diagnostic intravascular catheter. II
  870.1210 Continuous flush catheter. II
  870.1230 Fiberoptic oximeter catheter. II
  870.1240 Flow-directed catheter. II
  870.1250 Percutaneous catheter. II
  870.1270 Intracavitary phonocatheter system. II
  870.1280 Steerable catheter. II
  870.1290 Steerable catheter control system. II
  870.1300 Catheter cannula. II
  870.1310 Vessel dilator for percutaneous catheterization. II
  870.1330 Catheter guide wire. II
  870.1340 Catheter introducer. II
  870.1370 Catheter tip occluder. II
  870.1380 Catheter stylet. II
  870.1390 Trocar. II
  870.1425 Programmable diagnostic computer. II
  870.1435 Single-function, preprogrammed diagnostic computer. II
  870.1450 Densitometer. II
  870.1650 Angiographic injector and syringe. II
  870.1660 Indicator injector. II
  870.1670 Syringe actuator for an injector. II
  870.1800 Withdrawal-infusion pump. II
  870.1875 Stethoscope. II
  870.1915 Thermodilution probe. II
  870.2050 Biopotential amplifier and signal conditioner. II
  870.2060 Transducer signal amplifier and conditioner. II
  870.2100 Cardiovascular blood flowmeter. II
  870.2120 Extravascular blood flow probe. II
  870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II
  870.2330 Echocardiograph. II
  870.2340 Electrocardiograph. II
  870.2350 Electrocardiograph lead switching adaptor. II
  870.2360 Electrocardiograph electrode. II
  870.2370 Electrocardiograph surface electrode tester. II
  870.2400 Vectorcardiograph. II
  870.2450 Medical cathode-ray tube display. II
  870.2675 Oscillometer. II
  870.2750 Impedance phlebograph. II
  870.2770 Impedance plethysmograph. II
  870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. II
  870.2800 Medical magnetic tape recorder. II
  870.2840 Apex cardiographic transducer. II
  870.2850 Extravascular blood pressure transducer. II
  870.2860 Heart sound transducer. II
  870.2870 Catheter tip pressure transducer. II
  870.2880 Ultrasonic transducer. II
  870.2890 Vessel occlusion transducer. II
  870.2900 Patient transducer and electrode cable (including connector). II
  870.2910 Radiofrequency physiological signal transmitter and receiver. II
  870.2920 Telephone electrocardiograph transmitter and receiver. II
  870.3630 Pacemaker generator function analyzer. II
  870.3640 Indirect pacemaker generator function analyzer. II
  870.3720 Pacemaker electrode function tester. II
  870.4075 Endomyocardial biopsy device. II
  870.4205 Cardiopulmonary bypass bubble detector. II
  870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. II
  870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter. II
  870.4280 Cardiopulmonary prebypass filter. II
  870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. II
  870.4310 Cardiopulmonary bypass coronary pressure gauge. II
  870.4330 Cardiopulmonary bypass on-line blood gas monitor. II
  870.4340 Cardiopulmonary bypass level sensing monitor and/or control. II
  870.4390 Cardiopulmonary bypass pump tubing. II
  870.4400 Cardiopulmonary bypass blood reservoir. II
  870.4410 Cardiopulmonary bypass in-line blood gas sensor. II
  870.4420 Cardiopulmonary bypass cardiotomy return sucker. II
  870.4430 Cardiopulmonary bypass intracardiac suction control. II
  870.4450 Vascular clamp. II
  870.4475 Surgical vessel dilator. II
  870.4875 Intraluminal artery stripper. II
  870.4885 External vein stripper. II
  870.5050 Patient care suction apparatus. II
  870.5150 Embolectomy catheter. II
  870.5175 Septostomy catheter. II
  870.5325 Defibrillator tester. II
  870.5800 Compressible limb sleeve. II
  870.5900 Thermal regulating system. II
  870.5925 Automatic rotating tourniquet. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1720 Pulp tester. II
  872.1740 Caries detection device. II
  872.1800 Extraoral source x-ray system. II
  872.1810 Intraoral source x-ray system. II
  872.1830 Cephalometer. II
  872.1870 Sulfide detection device. II
  872.3060 Noble metal alloy. II
  872.3200 Resin tooth bonding agent. II
  872.3250 Calcium hydroxide cavity liner. II
  872.3260 Cavity varnish. II
  872.3275 Dental cement. II
  872.3300 Hydrophilic resin coating for dentures. II
  872.3310 Coating material for resin fillings. II
  872.3520 OTC denture cleanser. I
  872.3540 OTC denture cushion or pad. II
  872.3560 OTC denture reliner. II
  872.3570 OTC denture repair kit. II
  872.3590 Preformed plastic denture tooth. II
  872.3600 Partially fabricated denture kit. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.3710 Base metal alloy. II
  872.3750 Bracket adhesive resin and tooth conditioner. II
  872.3760 Denture relining, repairing, or rebasing resin. II
  872.3765 Pit and fissure sealant and conditioner. II
  872.3770 Temporary crown and bridge resin. II
  872.3820 Root canal filling resin. II
  872.3890 Endodontic stabilizing splint. II
  872.3920 Porcelain tooth. II
  872.4120 Bone cutting instrument and accessories. II
  872.4200 Dental handpiece and accessories. I
  872.4465 Gas-powered jet injector. II
  872.4475 Spring-powered jet injector. II
  872.4565 Dental hand instrument. I
  872.4840 Rotary scaler. II
  872.4850 Ultrasonic scaler. II
  872.4920 Dental electrosurgical unit and accessories. II
  872.5470 Orthodontic plastic bracket. II
  872.5500 Extraoral orthodontic headgear. II
  872.5550 Teething ring. II
  872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II
  872.6070 Ultraviolet activator for polymerization. II
  872.6080 Airbrush. II
  872.6250 Dental chair and accessories. I
  872.6350 Ultraviolet detector. II
  872.6640 Dental operative unit and accessories. I
  872.6660 Porcelain powder for clinical use. II
  872.6710 Boiling water sterilizer. I
  872.6770 Cartridge syringe. II
PanelSection Number       Regulation Name / Device Name      Class
Ear Nose & Throat
  874.1090 Auditory impedance tester. II
  874.1120 Electronic noise generator for audiometric testing. II
  874.1325 Electroglottograph. II
  874.1820 Surgical nerve stimulator/locator. II
  874.3300 Hearing Aid. II
  874.3310 Hearing aid calibrator and analysis system. II
  874.3320 Group hearing aid or group auditory trainer. II
  874.3330 Master hearing aid. II
  874.3400 Tinnitus masker. II
  874.3730 Laryngeal prosthesis (Taub design). II
  874.4250 Ear, nose, and throat electric or pneumatic surgical drill. II
  874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. II
  874.4680 Bronchoscope (flexible or rigid) and accessories. II
  874.4710 Esophagoscope (flexible or rigid) and accessories. II
  874.4720 Mediastinoscope and accessories. II
  874.4760 Nasopharyngoscope (flexible or rigid) and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1075 Gastroenterology-urology biopsy instrument. II
  876.1500 Endoscope and accessories. II
  876.1725 Gastrointestinal motility monitoring system. II
  876.4020 Fiberoptic light ureteral catheter. II
  876.4270 Colostomy rod. II
  876.4300 Endoscopic electrosurgical unit and accessories. II
  876.4400 Hemorrhoidal ligator. II
  876.4480 Electrohydraulic lithotriptor. II
  876.4500 Mechanical lithotriptor. II
  876.4620 Ureteral stent. II
  876.4770 Urethrotome. II
  876.5010 Biliary catheter and accessories. II
  876.5090 Suprapubic urological catheter and accessories. II
  876.5130 Urological catheter and accessories. II
  876.5160 Urological clamp for males. I
  876.5320 Nonimplanted electrical continence device. II
  876.5365 Esophageal dilator. II
  876.5470 Ureteral dilator. II
  876.5520 Urethral dilator. II
  876.5540 Blood access device and accessories. II
  876.5665 Water purification system for hemodialysis. II
  876.5880 Isolated kidney perfusion and transport system and accessories. II
  876.5895 Ostomy irrigator. II
  876.5980 Gastrointestinal tube and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.1860 Immunohistochemistry reagents and kits. II
  864.5260 Automated cell-locating device. II
  864.5300 Red cell indices device. II
  864.5425 Multipurpose system for in vitro coagulation studies. II
  864.5600 Automated hematocrit instrument. II
  864.5620 Automated hemoglobin system. II
  864.5950 Blood volume measuring device. II
  864.6550 Occult blood test. II
  864.7040 Adenosine triphosphate release assay. I
  864.7100 Red blood cell enzyme assay. II
  864.7250 Erythropoietin assay. II
  864.7275 Euglobulin lysis time tests. II
  864.7300 Fibrin monomer paracoagulation test. II
  864.7320 Fibrinogen/fibrin degradation products assay. II
  864.7340 Fibrinogen determination system. II
  864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay. II
  864.7375 Glutathione reductase assay. II
  864.7400 Hemoglobin A2 assay. II
  864.7415 Abnormal hemoglobin assay. II
  864.7425 Carboxyhemoglobin assay. II
  864.7440 Electrophoretic hemoglobin analysis system. II
  864.7455 Fetal hemoglobin assay. II
  864.7470 Glycosylated hemoglobin assay. II
  864.7490 Sulfhemoglobin assay. II
  864.7500 Whole blood hemoglobin assays. II
  864.7825 Sickle cell test. II
  864.8100 Bothrops atrox reagent. II
  864.8150 Calibrator for cell indices. II
  864.8165 Calibrator for hemoglobin or hematocrit measurement. II
  864.8175 Calibrator for platelet counting. II
  864.8185 Calibrator for red cell and white cell counting. II
  864.8625 Hematology quality control mixture. II
  864.8950 Russell viper venom reagent. I
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2420 Electronic monitor for gravity flow infusion systems. II
  880.2460 Electrically powered spinal fluid pressure monitor. II
  880.2500 Spinal fluid manometer. II
  880.2800 Sterilization process indicator. II
  880.2910 Clinical electronic thermometer. II
  880.5025 I.V. container. II
  880.5045 Medical recirculating air cleaner. II
  880.5090 Liquid bandage. I
  880.5130 Infant radiant warmer. II
  880.5200 Intravascular catheter. II
  880.5400 Neonatal incubator. II
  880.5410 Neonatal transport incubator. II
  880.5430 Nonelectrically powered fluid injector. II
  880.5440 Intravascular administration set. II
  880.5450 Patient care reverse isolation chamber. II
  880.5570 Hypodermic single lumen needle. II
  880.5580 Acupuncture needle. II
  880.5680 Pediatric position holder. I
  880.5700 Neonatal phototherapy unit. II
  880.5725 Infusion pump. II
  880.5780 Medical support stocking. II
  880.5860 Piston syringe. II
  880.6100 Ethylene oxide gas aerator cabinet. II
  880.6250 Patient examination glove. I
  880.6375 Patient lubricant. I
  880.6500 Medical ultraviolet air purifier. II
  880.6710 Medical ultraviolet water purifier. II
  880.6760 Protective restraint. I
  880.6850 Sterilization wrap. II
  880.6860 Ethylene oxide gas sterilizer. II
  880.6870 Dry-heat sterilizer. II
  880.6880 Steam sterilizer. II
  880.6885 Liquid chemical sterilants/high level disinfectants. II
  880.6920 Syringe needle introducer. II
PanelSection Number       Regulation Name / Device Name      Class
Immunology
  866.5080 Alpha-1-antichymotrypsin immunological test system. II
  866.5090 Antimitochondrial antibody immunological test system. II
  866.5100 Antinuclear antibody immunological test system. II
  866.5120 Antismooth muscle antibody immunological test system. II
  866.5130 Alpha-1-antitrypsin immunological test system. II
  866.5150 Bence-Jones proteins immunological test system. II
  866.5240 Complement components immunological test system. II
  866.5250 Complement C2 inhibitor (inactivator) immunological test system. II
  866.5260 Complement C3b inactivator immunological test system. II
  866.5270 C-reactive protein immunological test system. II
  866.5340 Ferritin immunological test system. II
  866.5350 Fibrinopeptide A immunological test system. II
  866.5510 Immunoglobulins A, G, M, D, and E immunological test system. II
  866.5550 Immunoglobulin (light chain specific) immunological test system. II
  866.5580 Alpha-1-lipoprotein immunological test system. II
  866.5600 Low-density lipoprotein immunological test system. II
  866.5620 Alpha-2-macroglobulin immunological test system. II
  866.5630 Beta-2-microglobulin immunological test system. II
  866.5640 Infectious mononucleosis immunological test system. II
  866.5680 Myoglobin immunological test system. II
  866.5775 Rheumatoid factor immunological test system. II
  866.5820 Systemic lupus erythematosus immunological test system. II
  866.5870 Thyroid autoantibody immunological test system. II
  866.5880 Transferrin immunological test system. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.1640 Antimicrobial susceptibility test powder. II
  866.1700 Culture medium for antimicrobial susceptibility tests. II
  866.2390 Transport culture medium. I
  866.2560 Microbial growth monitor. I
  866.2850 Automated zone reader. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3110 Campylobacter fetus serological reagents. I
  866.3120 Chlamydia serological reagents. I
  866.3175 Cytomegalovirus serological reagents. II
  866.3235 Epstein-Barr virus serological reagents. I
  866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I
  866.3390 Neisseria spp. direct serological test reagents. II
  866.3510 Rubella virus serological reagents. II
  866.3780 Toxoplasma gondii serological reagents. II
  866.3820 Treponema pallidum nontreponemal test reagents. II
  866.3830 Treponema pallidum treponemal test reagents. II
  866.3870 Trypanosoma spp. serological reagents. I
  866.3900 Varicella-zoster virus serological reagents. II
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1020 Rigidity analyzer. II
  882.1030 Ataxiagraph. I
  882.1240 Echoencephalograph. II
  882.1275 Electroconductive media. II
  882.1310 Cortical electrode. II
  882.1320 Cutaneous electrode. II
  882.1330 Depth electrode. II
  882.1340 Nasopharyngeal electrode. II
  882.1350 Needle electrode. II
  882.1400 Electroencephalograph. II
  882.1420 Electroencephalogram (EEG) signal spectrum analyzer. I
  882.1460 Nystagmograph. II
  882.1480 Neurological endoscope. II
  882.1540 Galvanic skin response measurement device. II
  882.1550 Nerve conduction velocity measurement device. II
  882.1560 Skin potential measurement device. II
  882.1570 Powered direct-contact temperature measurement device. II
  882.1610 Alpha monitor. II
  882.1620 Intracranial pressure monitoring device. II
  882.1835 Physiological signal amplifier. II
  882.1845 Physiological signal conditioner. II
  882.1855 Electroencephalogram (EEG) telemetry system. II
  882.1870 Evoked response electrical stimulator. II
  882.1880 Evoked response mechanical stimulator. II
  882.1890 Evoked response photic stimulator. II
  882.1900 Evoked response auditory stimulator. II
  882.1950 Tremor transducer. II
  882.4060 Ventricular cannula. I
  882.4100 Ventricular catheter. II
  882.4150 Scalp clip. II
  882.4175 Aneurysm clip applier. II
  882.4250 Cryogenic surgical device. II
  882.4275 Dowel cutting instrument. II
  882.4300 Manual cranial drills, burrs, trephines, and their accessories II
  882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. II
  882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. II
  882.4360 Electric cranial drill motor. II
  882.4370 Pneumatic cranial drill motor. II
  882.4400 Radiofrequency lesion generator. II
  882.4460 Neurosurgical head holder (skull clamp). II
  882.4545 Shunt system implantation instrument. I
  882.4560 Stereotaxic instrument. II
  882.4700 Neurosurgical paddie. II
  882.4725 Radiofrequency lesion probe. II
  882.4800 Self-retaining retractor for neurosurgery. II
  882.4840 Manual rongeur. II
  882.4845 Powered rongeur. II
  882.5070 Bite block. II
  882.5235 Aversive conditioning device. II
  882.5500 Lesion temperature monitor. II
  882.5550 Central nervous system fluid shunt and components. II
  882.5810 External functional neuromuscular stimulator. II
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
  882.5960 Skull tongs for traction. II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  884.1050 Endocervical aspirator. II
  884.1060 Endometrial aspirator. II
  884.1100 Endometrial brush. II
  884.1175 Endometrial suction curette and accessories. II
  884.1185 Endometrial washer. II
  884.1300 Uterotubal carbon dioxide insufflator and accessories. II
  884.1560 Fetal blood sampler. II
  884.1630 Colposcope. II
  884.1660 Transcervical endoscope (amnioscope) and accessories. II
  884.1690 Hysteroscope and accessories. II
  884.1700 Hysteroscopic insufflator. II
  884.1720 Gynecologic laparoscope and accessories. II
  884.1730 Laparoscopic insufflator. II
  884.2225 Obstetric-gynecologic ultrasonic imager. II
  884.2600 Fetal cardiac monitor. II
  884.2640 Fetal phonocardiographic monitor and accessories. II
  884.2660 Fetal ultrasonic monitor and accessories. II
  884.2675 Fetal scalp circular (spiral) electrode and applicator. II
  884.2700 Intrauterine pressure monitor and accessories. II
  884.2720 External uterine contraction monitor and accessories. II
  884.2740 Perinatal monitoring system and accessories. II
  884.2960 Obstetric ultrasonic transducer and accessories. II
  884.2980 Telethermographic system. I
  884.2982 Liquid crystal thermographic system. I
  884.3200 Cervical drain. II
  884.3575 Vaginal pessary. II
  884.3900 Vaginal stent. II
  884.4120 Gynecologic electrocautery and accessories. II
  884.4160 Unipolar endoscopic coagulator-cutter and accessories. II
  884.4260 Hygroscopic Laminaria cervical dilator. II
  884.4340 Fetal vacuum extractor. II
  884.4400 Obstetric forceps. II
  884.4500 Obstetric fetal destructive instrument. II
  884.4530 Obstetric-gynecologic specialized manual instrument. II
  884.4550 Gynecologic surgical laser. II
  884.4900 Obstetric table and accessories. II
  884.5070 Vacuum abortion system. II
  884.5100 Obstetric anesthesia set. II
  884.5160 Powered breast pump. II
  884.5250 Cervical cap. II
  884.5300 Condom. II
  884.5310 Condom with spermicidal lubricant. II
  884.5350 Contraceptive diaphragm and accessories. II
  884.5390 Perineal heater. II
  884.5400 Menstrual cup. II
  884.5425 Scented or scented deodorized menstrual pad. II
  884.5460 Scented or scented deodorized menstrual tampon. II
  884.5470 Unscented menstrual tampon. II
  884.5960 Genital vibrator for therapeutic use. II
  884.6100 Assisted reproduction needles. II
  884.6110 Assisted reproduction catheters. II
  884.6120 Assisted reproduction accessories. II
  884.6130 Assisted reproduction microtools. II
  884.6140 Assisted reproduction micropipette fabrication instruments. II
  884.6150 Assisted reproduction micromanipulators and microinjectors. II
  884.6160 Assisted reproduction labware. II
  884.6180 Reproductive media and supplements. II
  884.6190 Assisted reproductive microscopes and microscope accessories. I
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1225 Chronaximeter. II
  890.1375 Diagnostic electromyograph. II
  890.1385 Diagnostic electromyograph needle electrode. II
  890.1450 Powered reflex hammer. II
  890.1850 Diagnostic muscle stimulator. II
  890.3110 Electric positioning chair. II
  890.3690 Powered wheeled stretcher. II
  890.3800 Motorized three-wheeled vehicle. II
  890.3850 Mechanical wheelchair. I
  890.3860 Powered wheelchair. II
  890.3880 Special grade wheelchair. II
  890.3900 Standup wheelchair. II
  890.3930 Wheelchair elevator. II
  890.5100 Immersion hydrobath. II
  890.5110 Paraffin bath. II
  890.5150 Powered patient transport. II
  890.5250 Moist steam cabinet. II
  890.5275 Microwave diathermy. II
  890.5290 Shortwave diathermy. II
  890.5300 Ultrasonic diathermy. II
  890.5360 Measuring exercise equipment. II
  890.5500 Infrared lamp. II
  890.5525 Iontophoresis device. II
  890.5575 Powered external limb overload warning device. II
  890.5650 Powered inflatable tube massager. II
  890.5710 Hot or cold disposable pack. I
  890.5850 Powered muscle stimulator. II
  890.5860 Ultrasound and muscle stimulator. II
  890.5880 Multi-function physical therapy table. II
  890.5900 Power traction equipment. II
PanelSection Number       Regulation Name / Device Name      Class
Radiology
  892.1000 Magnetic resonance diagnostic device. II
  892.1100 Scintillation (gamma) camera. I
  892.1110 Positron camera. I
  892.1170 Bone densitometer. II
  892.1200 Emission computed tomography system. II
  892.1220 Fluorescent scanner. II
  892.1310 Nuclear tomography system. II
  892.1360 Radionuclide dose calibrator. II
  892.1390 Radionuclide rebreathing system. II
  892.1540 Nonfetal ultrasonic monitor. II
  892.1550 Ultrasonic pulsed doppler imaging system. II
  892.1560 Ultrasonic pulsed echo imaging system. II
  892.1570 Diagnostic ultrasonic transducer. II
  892.1600 Angiographic x-ray system. II
  892.1610 Diagnostic x-ray beam-limiting device. II
  892.1620 Cine or spot fluorographic x-ray camera. II
  892.1630 Electrostatic x-ray imaging system. II
  892.1650 Image-intensified fluoroscopic x-ray system. II
  892.1660 Non-image-intensified fluoroscopic x-ray system. II
  892.1670 Spot-film device. II
  892.1680 Stationary x-ray system. II
  892.1710 Mammographic x-ray system. II
  892.1720 Mobile x-ray system. II
  892.1730 Photofluorographic x-ray system. II
  892.1740 Tomographic x-ray system. II
  892.1750 Computed tomography x-ray system. II
  892.1820 Pneumoencephalographic chair. II
  892.1850 Radiographic film cassette. II
  892.1860 Radiographic film/cassette changer. II
  892.1870 Radiographic film/cassette changer programmer. II
  892.1900 Automatic radiographic film processor. II
  892.2030 Medical image digitizer. II
  892.2040 Medical image hardcopy device. II
  892.2050 Picture archiving and communications system. II
  892.5050 Medical charged-particle radiation therapy system. II
  892.5300 Medical neutron radiation therapy system. II
  892.5700 Remote controlled radionuclide applicator system. II
  892.5710 Radiation therapy beam-shaping block. II
  892.5730 Radionuclide brachytherapy source. II
  892.5750 Radionuclide radiation therapy system. II
  892.5770 Powered radiation therapy patient support assembly. II
  892.5840 Radiation therapy simulation system. II
  892.5900 X-ray radiation therapy system. II
  892.5930 Therapeutic x-ray tube housing assembly. II
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 Surgical apparel. II
  878.4350 Cryosurgical unit and accessories. II
  878.4370 Surgical drape and drape accessories. II
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
  878.4460 Surgeon's glove. I
  878.4580 Surgical lamp. II
  878.4630 Ultraviolet lamp for dermatologic disorders. II
  878.4780 Powered suction pump. II
  878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. II
  878.5040 Suction lipoplasty system. II
  878.5070 Air-handling apparatus for a surgical operating room. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3030 Acetaminophen test system. II
  862.3035 Amikacin test system. II
  862.3040 Alcohol test system. II
  862.3050 Breath-alcohol test system. I
  862.3100 Amphetamine test system. II
  862.3110 Antimony test system. I
  862.3120 Arsenic test system. I
  862.3150 Barbiturate test system. II
  862.3170 Benzodiazepine test system. II
  862.3200 Clinical toxicology calibrator. II
  862.3220 Carbon monoxide test system. I
  862.3240 Cholinesterase test system. I
  862.3250 Cocaine and cocaine metabolite test system. II
  862.3270 Codeine test system. II
  862.3280 Clinical toxicology control material. I
  862.3300 Digitoxin test system. II
  862.3320 Digoxin test system. II
  862.3350 Diphenylhydantoin test system. II
  862.3380 Ethosuximide test system. II
  862.3450 Gentamicin test system. II
  862.3520 Kanamycin test system. II
  862.3550 Lead test system. II
  862.3555 Lidocaine test system. II
  862.3560 Lithium test system. II
  862.3580 Lysergic acid diethylamide (LSD) test system. II
  862.3600 Mercury test system. I
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3630 Methaqualone test system. II
  862.3640 Morphine test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
  862.3650 Opiate test system. II
  862.3660 Phenobarbital test system. II
  862.3670 Phenothiazine test system. II
  862.3680 Primidone test system. II
  862.3700 Propoxyphene test system. II
  862.3750 Quinine test system. I
  862.3830 Salicylate test system. II
  862.3850 Sulfonamide test system. I
  862.3880 Theophylline test system. II
  862.3900 Tobramycin test system. II
  862.3910 Tricyclic antidepressant drugs test system. II
  862.3950 Vancomycin test system. II
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