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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device computer, oxygen-uptake
Regulation Description Oxygen uptake computer.
Product CodeBZL
Regulation Number 868.1730
Device Class 2


Premarket Reviews
ManufacturerDecision
ICOR
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1

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