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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 electrocardiograph, ambulatory, with analysis algorithm
Regulation Description Medical magnetic tape recorder.
Product CodeMLO
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BITTIUM BIOSIGNALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABTECH KFT.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 1


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