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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, oxygen, partial pressure, blood-phase, indwelling
Regulation Description Indwelling blood oxygen partial pressure (PO2) analyzer.
Product CodeCCE
Regulation Number 868.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2

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