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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plethysmograph, impedance
Regulation Description Impedance plethysmograph.
Product CodeDSB
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
BODYPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOSET MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPEDIMED LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MODE SENSORS AS
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

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