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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, enflurane, gaseous-phase (anesthetic concentration)
Regulation Description Enflurane gas analyzer.
Product CodeCBQ
Regulation Number 868.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICOR
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

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