This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.
As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page. |
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CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
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| CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL |
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BLDG. 16, 321 KUANG FU RD,SEC2
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HSINCHU
TW
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| alberttwli@itri.org.tw |
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| | contact: | ALBERT T.W. LI, MANAGER, OFFICE OF MEDICAL DEVICE EVALUATION |
| phone: | 886 357 32227 |
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| Panel | Section Number | Regulation Name / Device Name | Class |
| Anesthesiology |
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868.5440 |
Portable oxygen generator. |
II |
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868.5915 |
Manual emergency ventilator. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
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862.1050 |
Alkaline phosphatase or isoenzymes test system. |
II |
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862.1065 |
Ammonia test system. |
I |
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862.1110 |
Bilirubin (total or direct) test system. |
II |
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862.1113 |
Bilirubin (total and unbound) in the neonate test system. |
I |
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862.1120 |
Blood gases (PCO2, PO2) and blood pH test system. |
II |
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862.1155 |
Human chorionic gonadotropin (HCG) test system. |
II |
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862.1160 |
Bicarbonate/carbon dioxide test system. |
II |
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862.1170 |
Chloride test system. |
II |
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862.1225 |
Creatinine test system. |
II |
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862.1310 |
Galactose test system. |
I |
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862.1340 |
Urinary glucose (nonquantitative) test system. |
II |
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862.1345 |
Glucose test system. |
II |
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862.1450 |
Lactic acid test system. |
I |
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862.1475 |
Lipoprotein test system. |
I |
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862.1495 |
Magnesium test system. |
I |
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862.1600 |
Potassium test system. |
II |
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862.1665 |
Sodium test system. |
II |
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862.1675 |
Blood specimen collection device. |
II |
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862.1680 |
Testosterone test system. |
I |
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862.1690 |
Thyroid stimulating hormone test system. |
II |
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862.1695 |
Free thyroxine test system. |
II |
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862.1730 |
Free tyrosine test system. |
I |
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862.1770 |
Urea nitrogen test system. |
II |
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862.1775 |
Uric acid test system. |
I |
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862.1825 |
Vitamin D test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Cardiovascular |
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870.1120 |
Blood pressure cuff. |
II |
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870.1130 |
Noninvasive blood pressure measurement system. |
II |
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870.2300 |
Cardiac monitor (including cardiotachometer and rate alarm). |
II |
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870.2330 |
Echocardiograph. |
II |
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870.2340 |
Electrocardiograph. |
II |
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870.2350 |
Electrocardiograph lead switching adaptor. |
II |
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870.2370 |
Electrocardiograph surface electrode tester. |
II |
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870.2700 |
Oximeter. |
II |
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870.2880 |
Ultrasonic transducer. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Dental |
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872.1800 |
Extraoral source x-ray system. |
II |
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872.1810 |
Intraoral source x-ray system. |
II |
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872.3200 |
Resin tooth bonding agent. |
II |
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872.3275 |
Dental cement. |
II |
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872.3660 |
Impression material. |
II |
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872.3690 |
Tooth shade resin material. |
II |
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872.4200 |
Dental handpiece and accessories. |
I |
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872.4850 |
Ultrasonic scaler. |
II |
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872.6070 |
Ultraviolet activator for polymerization. |
II |
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872.6250 |
Dental chair and accessories. |
I |
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872.6640 |
Dental operative unit and accessories. |
I |
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872.6710 |
Boiling water sterilizer. |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Gastroenterology |
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876.1075 |
Gastroenterology-urology biopsy instrument. |
I |
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876.1075 |
Gastroenterology-urology biopsy instrument. |
II |
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876.1500 |
Endoscope and accessories. |
II |
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876.4300 |
Endoscopic electrosurgical unit and accessories. |
II |
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876.4480 |
Electrohydraulic lithotriptor. |
II |
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876.4500 |
Mechanical lithotriptor. |
II |
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876.4620 |
Ureteral stent. |
II |
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876.5010 |
Biliary catheter and accessories. |
II |
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876.5130 |
Urological catheter and accessories. |
II |
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876.5130 |
Urological catheter and accessories. |
N |
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876.5320 |
Nonimplanted electrical continence device. |
II |
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876.5540 |
Blood access device and accessories. |
I |
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876.5540 |
Blood access device and accessories. |
II |
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876.5665 |
Water purification system for hemodialysis. |
II |
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876.5820 |
Hemodialysis system and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Hematology |
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864.5220 |
Automated differential cell counter. |
II |
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864.5425 |
Multipurpose system for in vitro coagulation studies. |
II |
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864.5700 |
Automated platelet aggregation system. |
II |
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864.6550 |
Occult blood test. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General Hospital |
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880.2910 |
Clinical electronic thermometer. |
II |
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880.5090 |
Liquid bandage. |
I |
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880.5200 |
Intravascular catheter. |
II |
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880.5400 |
Neonatal incubator. |
II |
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880.5410 |
Neonatal transport incubator. |
II |
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880.5440 |
Intravascular administration set. |
II |
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880.5570 |
Hypodermic single lumen needle. |
II |
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880.5680 |
Pediatric position holder. |
I |
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880.5860 |
Piston syringe. |
II |
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880.6250 |
Non-powdered patient examination glove. |
I |
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880.6375 |
Patient lubricant. |
I |
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880.6850 |
Sterilization wrap. |
II |
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880.6880 |
Steam sterilizer. |
II |
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880.6885 |
Liquid chemical sterilants/high level disinfectants. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Immunology |
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866.5270 |
C-reactive protein immunological test system. |
II |
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866.5340 |
Ferritin immunological test system. |
II |
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866.5600 |
Low-density lipoprotein immunological test system. |
II |
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866.5775 |
Rheumatoid factor immunological test system. |
II |
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866.5880 |
Transferrin immunological test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Microbiology |
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866.1620 |
Antimicrobial susceptibility test disc. |
II |
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866.1640 |
Antimicrobial susceptibility test powder. |
II |
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866.2390 |
Transport culture medium. |
I |
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866.2560 |
Microbial growth monitor. |
I |
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866.2850 |
Automated zone reader. |
I |
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866.2900 |
Microbiological specimen collection and transport device. |
I |
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866.3110 |
Campylobacter fetus serological reagents. |
I |
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866.3120 |
Chlamydia serological reagents. |
I |
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866.3235 |
Epstein-Barr virus serological reagents. |
I |
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866.3370 |
Mycobacterium tuberculosis immunofluorescent reagents. |
I |
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866.3870 |
Trypanosoma spp. serological reagents. |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Neurology |
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882.1030 |
Ataxiagraph. |
I |
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882.1240 |
Echoencephalograph. |
II |
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882.1310 |
Cortical electrode. |
II |
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882.1320 |
Cutaneous electrode. |
II |
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882.1400 |
Electroencephalograph. |
II |
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882.1420 |
Electroencephalogram (EEG) signal spectrum analyzer. |
I |
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882.5890 |
Transcutaneous electrical nerve stimulator for pain relief. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Obstetrics/Gynecology |
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884.1690 |
Hysteroscope and accessories. |
II |
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884.1700 |
Hysteroscopic insufflator. |
II |
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884.1720 |
Gynecologic laparoscope and accessories. |
II |
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884.1730 |
Laparoscopic insufflator. |
I |
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884.2225 |
Obstetric-gynecologic ultrasonic imager. |
II |
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884.2660 |
Fetal ultrasonic monitor and accessories. |
II |
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884.2960 |
Obstetric ultrasonic transducer and accessories. |
II |
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884.4120 |
Gynecologic electrocautery and accessories. |
II |
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884.4550 |
Gynecologic surgical laser. |
II |
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884.5300 |
Condom. |
II |
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884.5310 |
Condom with spermicidal lubricant. |
II |
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884.5460 |
Scented or scented deodorized menstrual tampon. |
II |
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884.5470 |
Unscented menstrual tampon. |
II |
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884.6100 |
Assisted reproduction needles. |
II |
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884.6110 |
Assisted reproduction catheters. |
II |
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884.6120 |
Assisted reproduction accessories. |
II |
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884.6130 |
Assisted reproduction microtools. |
II |
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884.6140 |
Assisted reproduction micropipette fabrication instruments. |
II |
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884.6160 |
Assisted reproduction labware. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ophthalmic |
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886.1570 |
Ophthalmoscope. |
II |
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886.1850 |
AC-powered slitlamp biomicroscope. |
II |
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886.3400 |
Keratoprosthesis. |
II |
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886.4150 |
Vitreous aspiration and cutting instrument. |
II |
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886.4300 |
Intraocular lens guide. |
I |
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886.4370 |
Keratome. |
I |
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886.4390 |
Ophthalmic laser. |
II |
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886.4392 |
Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. |
II |
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886.4670 |
Phacofragmentation system. |
II |
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886.5916 |
Rigid gas permeable contact lens. |
II |
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886.5918 |
Rigid gas permeable contact lens care products. |
II |
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886.5925 |
Soft (hydrophilic) contact lens. |
II |
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886.5928 |
Soft (hydrophilic) contact lens care products. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Physical Medicine |
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890.1385 |
Diagnostic electromyograph needle electrode. |
II |
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890.3800 |
Motorized three-wheeled vehicle. |
II |
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890.3850 |
Mechanical wheelchair. |
I |
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890.3860 |
Powered wheelchair. |
II |
| |
890.3880 |
Special grade wheelchair. |
II |
| |
890.3900 |
Standup wheelchair. |
II |
| |
890.5500 |
Infrared lamp. |
II |
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890.5710 |
Hot or cold disposable pack. |
I |
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890.5850 |
Powered muscle stimulator. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Radiology |
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892.1000 |
Magnetic resonance diagnostic device. |
II |
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892.1100 |
Scintillation (gamma) camera. |
I |
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892.1110 |
Positron camera. |
I |
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892.1200 |
Emission computed tomography system. |
II |
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892.1310 |
Nuclear tomography system. |
II |
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892.1360 |
Radionuclide dose calibrator. |
II |
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892.1540 |
Nonfetal ultrasonic monitor. |
II |
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892.1550 |
Ultrasonic pulsed doppler imaging system. |
II |
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892.1560 |
Ultrasonic pulsed echo imaging system. |
II |
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892.1570 |
Diagnostic ultrasonic transducer. |
II |
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892.1620 |
Cine or spot fluorographic x-ray camera. |
II |
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892.1630 |
Electrostatic x-ray imaging system. |
II |
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892.1650 |
Image-intensified fluoroscopic x-ray system. |
II |
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892.1680 |
Stationary x-ray system. |
II |
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892.1710 |
Mammographic x-ray system. |
II |
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892.1720 |
Mobile x-ray system. |
II |
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892.1740 |
Tomographic x-ray system. |
II |
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892.1750 |
Computed tomography x-ray system. |
II |
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892.2050 |
Picture archiving and communications system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General & Plastic Surgery |
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878.4040 |
Surgical apparel. |
II |
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878.4400 |
Electrosurgical cutting and coagulation device and accessories. |
II |
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878.4460 |
Non-powdered surgeon's glove. |
I |
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878.4580 |
Surgical lamp. |
II |
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878.4780 |
Powered suction pump. |
II |
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878.4800 |
Manual surgical instrument for general use. |
I |
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878.4810 |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Toxicology |
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862.3100 |
Amphetamine test system. |
II |
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862.3110 |
Antimony test system. |
I |
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862.3120 |
Arsenic test system. |
I |
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862.3150 |
Barbiturate test system. |
II |
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862.3250 |
Cocaine and cocaine metabolite test system. |
II |
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862.3270 |
Codeine test system. |
II |
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862.3600 |
Mercury test system. |
I |
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862.3610 |
Methamphetamine test system. |
II |
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862.3620 |
Methadone test system. |
II |
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862.3640 |
Morphine test system. |
II |
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862.3650 |
Opiate test system. |
II |
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862.3700 |
Propoxyphene test system. |
II |
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862.3750 |
Quinine test system. |
I |
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862.3850 |
Sulfonamide test system. |
I |
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862.3870 |
Cannabinoid test system. |
II |
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862.3910 |
Tricyclic antidepressant drugs test system. |
II |
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