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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 10/27/2014

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 To-date, FDA has not withdrawn accreditation from any Accredited Person.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.
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
BLDG. 16, 321 KUANG FU RD,SEC2
HSINCHU    
CHINA (TAIWAN)
Contact: ALBERT T.W. LI, MANAGER, OFFICE OF MEDICAL DEVICE EVALUATION
Phone:886 357 32227
Fax: 357 32299
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.5630 Nebulizer. II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1065 Ammonia test system. I
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  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
  862.1225 Creatinine test system. II
  862.1310 Galactose test system. I
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1410 Iron (non-heme) test system. I
  862.1415 Iron-binding capacity test system. I
  862.1495 Magnesium test system. I
  862.1580 Phosphorus (inorganic) test system. I
  862.1600 Potassium test system. II
  862.1660 Quality control material (assayed and unassayed). I
  862.1665 Sodium test system. II
  862.1680 Testosterone test system. I
  862.1730 Free tyrosine test system. I
  862.1770 Urea nitrogen test system. II
  862.1775 Uric acid test system. I
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1120 Blood pressure cuff. II
  870.1130 Noninvasive blood pressure measurement system. 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
  870.2880 Ultrasonic transducer. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1800 Extraoral source x-ray system. II
  872.1810 Intraoral source x-ray system. II
  872.3060 Noble metal alloy. II
  872.3200 Resin tooth bonding agent. II
  872.3275 Dental cement. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.3710 Base metal alloy. II
  872.4200 Dental handpiece and accessories. I
  872.6250 Dental chair and accessories. I
  872.6640 Dental operative unit and accessories. I
  872.6710 Boiling water sterilizer. I
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1075 Gastroenterology-urology biopsy instrument. II
  876.1500 Endoscope and accessories. II
  876.4300 Endoscopic electrosurgical unit and accessories. 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
  876.5130 Urological catheter and accessories. II
  876.5160 Urological clamp for males. I
  876.5320 Nonimplanted electrical continence device. II
  876.5665 Water purification system for hemodialysis. II
  876.5820 Hemodialysis system and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2910 Clinical electronic thermometer. II
  880.5090 Liquid bandage. I
  880.5200 Intravascular catheter. II
  880.5400 Neonatal incubator. II
  880.5410 Neonatal transport incubator. II
  880.5440 Intravascular administration set. II
  880.5570 Hypodermic single lumen needle. II
  880.5680 Pediatric position holder. I
  880.5725 Infusion pump. II
  880.5860 Piston syringe. II
  880.6250 Patient examination glove. I
  880.6375 Patient lubricant. I
  880.6760 Protective restraint. I
  880.6880 Steam sterilizer. II
  880.6885 Liquid chemical sterilants/high level disinfectants. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.1640 Antimicrobial susceptibility test powder. 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
  866.3235 Epstein-Barr virus serological reagents. I
  866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I
  866.3870 Trypanosoma spp. serological reagents. I
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1030 Ataxiagraph. I
  882.1240 Echoencephalograph. II
  882.1310 Cortical electrode. II
  882.1320 Cutaneous electrode. II
  882.1400 Electroencephalograph. II
  882.1420 Electroencephalogram (EEG) signal spectrum analyzer. I
  882.1480 Neurological endoscope. II
  882.4060 Ventricular cannula. I
  882.4545 Shunt system implantation instrument. I
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  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
  884.2660 Fetal ultrasonic monitor and accessories. II
  884.2960 Obstetric ultrasonic transducer and accessories. II
  884.2980 Telethermographic system. I
  884.2982 Liquid crystal thermographic system. I
  884.4120 Gynecologic electrocautery and accessories. II
  884.4550 Gynecologic surgical laser. II
  884.5300 Condom. II
  884.5310 Condom with spermicidal lubricant. II
  884.5460 Scented or scented deodorized menstrual tampon. II
  884.5470 Unscented menstrual tampon. 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
Ophthalmic
  886.1570 Ophthalmoscope. II
  886.1780 Retinoscope. II
  886.1850 AC-powered slitlamp biomicroscope. II
  886.3400 Keratoprosthesis. II
  886.4070 Powered corneal burr. I
  886.4150 Vitreous aspiration and cutting instrument. II
  886.4300 Intraocular lens guide. I
  886.4370 Keratome. I
  886.4390 Ophthalmic laser. II
  886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. II
  886.4670 Phacofragmentation system. II
  886.5916 Rigid gas permeable contact lens. II
  886.5918 Rigid gas permeable contact lens care products. II
  886.5925 Soft (hydrophilic) contact lens. II
  886.5928 Soft (hydrophilic) contact lens care products. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1385 Diagnostic electromyograph needle electrode. 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
  890.5100 Immersion hydrobath. II
  890.5500 Infrared lamp. II
  890.5710 Hot or cold disposable pack. I
  890.5850 Powered muscle stimulator. 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
  892.1200 Emission computed tomography system. II
  892.1310 Nuclear tomography system. II
  892.1360 Radionuclide dose calibrator. 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
  892.1670 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
  892.1740 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
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
  878.4460 Surgeon's glove. I
  878.4580 Surgical lamp. II
  878.4780 Powered suction pump. II
  878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  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
  862.3200 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
  862.3600 Mercury test system. I
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3640 Morphine test system. II
  862.3650 Opiate test system. II
  862.3750 Quinine test system. I
  862.3850 Sulfonamide test system. I
  862.3870 Cannabinoid test system. II
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