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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, airway pressure (includes gauge and/or alarm)
Regulation Description Airway pressure monitor.
Product CodeCAP
Regulation Number 868.2600
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED
  SUBSTANTIALLY EQUIVALENT 2
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 2
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 2
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 1
Fire 1
Out-of-box failure 1
Total Device Problems 3

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