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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 flowmeter, blood, cardiovascular
Regulation Description Cardiovascular blood flowmeter.
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
DELTEX MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
OR-NIM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERIMED AB
  SUBSTANTIALLY EQUIVALENT 1
TRANSONIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 6
Noise, Audible 1
Disconnection 1
Device Operates Differently Than Expected 1
Insufficient Information 1
Total Device Problems 10

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II May-10-2016
2 Medistim Asa II Feb-26-2018
3 Transonic Systems Inc II Sep-03-2015
4 Vascular Technology, Inc. II Sep-12-2018

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