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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 plethysmograph, impedance
Product CodeDSB
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
BODYPORT INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPEDIMED LIMITED
  SUBSTANTIALLY EQUIVALENT 3
SENSIBLE MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation III Sep-26-2022
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