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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, blood, cardiovascular
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
DELTEX MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLOSONICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K183574  SRX Handheld Doppler, DMX Handheld Doppler, Obstet ...
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER ASSOCIATED SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RFPI
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jul-20-2023
2 Medistim Asa II Feb-26-2018
3 Vascular Technology, Inc. II Sep-12-2018
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