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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 04/21/2014

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 To-date, FDA has not withdrawn accreditation from any Accredited Person.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:MR. DAVE YUNGVIRT,
Phone: 212 332 3250 ext
Fax:
Email:
INFO@FDATHIRDPARTYREVIEW.COM
Internet:
http://www.fdathirdpartyreview.com
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  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 BINDING 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 PRESSUE 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 HANDPIECES 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
  884.5460 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
  890.5710 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
  892.2050 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS 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 GLOVES I
  878.4580 SURGICAL LAMP II
  878.4780 POWERED SUCTION PUMP II
  878.4810 LASER SURGICAL INSTRUMENT FOR USE IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY II
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: THIN LAYER CHROMATOGRAPHY  
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: RADIOIMMUNOASSAY  
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: ENZYME IMMUNOASSAY  
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