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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 09/22/2014

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 To-date, FDA has not withdrawn accreditation from any Accredited Person.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.
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK NY 10111    
Contact: DAVE YUNGVIRT
Phone: 212 3323250
Fax:
Internet:
http://www.fdathirdpartyreview.com
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.1400 Carbon dioxide gas analyzer. II
  868.2375 Breathing frequency monitor. II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  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
  862.1660 Quality control material (assayed and unassayed). I
  862.1680 Testosterone test system. I
  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
  870.1875 Stethoscope. 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
  870.2770 Impedance plethysmograph. II
  870.2880 Ultrasonic transducer. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.4200 Dental handpiece and accessories. I
  872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II
  872.6710 Boiling water sterilizer. I
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1500 Endoscope 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
  880.5725 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
Neurology
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  884.4120 Gynecologic electrocautery and accessories. II
  884.5300 Condom. II
  884.5310 Condom with spermicidal lubricant. II
  884.5400 Menstrual cup. II
  884.5460 Scented or scented deodorized menstrual tampon. II
  884.5470 Unscented menstrual tampon. II
PanelSection Number       Regulation Name / Device Name      Class
Ophthalmic
  886.4390 Ophthalmic laser. II
PanelSection Number       Regulation Name / Device Name      Class
Orthopedic
  888.1100 Arthroscope. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  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
  890.5500 Infrared lamp. II
  890.5650 Powered inflatable tube massager. 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
  892.1710 Mammographic x-ray system. II
  892.1750 Computed tomography x-ray system. II
  892.2050 Picture archiving and communications system. II
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 Surgical apparel. II
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
  878.4410 Low energy ultrasound wound cleaner. 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
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