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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocardiograph,ambulatory(without analysis)
Regulation Description Medical magnetic tape recorder.
Product CodeMWJ
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAEMAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIONET, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC MONITORING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 2
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ET MEDICAL DEVICES SPA
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GETEMED
  SUBSTANTIALLY EQUIVALENT 4
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-STAR INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 2
NORTHEAST MONITORING, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 1
Leak 1
Use of Device Issue 1
Total Device Problems 3

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