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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device recorder, magnetic tape, medical
Regulation Description Medical magnetic tape recorder.
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 2
DMS-SERVICE LLC
  SUBSTANTIALLY EQUIVALENT 2
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Problem 101
Appropriate Term/Code Not Available 2
Circuit Failure 2
Improper or Incorrect Procedure or Method 2
Device Operates Differently Than Expected 1
Device Displays Incorrect Message 1
No Apparent Adverse Event 1
False Negative Result 1
Incorrect Interpretation of signal 1
Output Problem 1
Temperature Problem 1
Total Device Problems 114


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