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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cable, transducer and electrode, patient, (including connector)
Product CodeDSA
Regulation Number 870.2900
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATRILITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUTHENTIC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURBELL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENERGETIC DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOGG SYSTEM COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRAL PROCESS SAS
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
KEPLER MEDTEC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC , INC.
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CORERAY TECHNOLOGY., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
  SUBSTANTIALLY EQUIVALENT 1
TIGER MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
TYCO ELECTRONICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
XINKANG MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Jan-07-2011
2 GE Healthcare, LLC III Jun-26-2019
3 GN Otometrics II Sep-23-2019
4 Philips North America, LLC II Sep-09-2019
5 Remington Medical Inc. II Apr-09-2014
6 Remington Medical Inc. II Aug-13-2010
7 Volcano Corp III Apr-12-2022
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