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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device meter, peak flow, spirometry
Regulation Description Peak-flow meter for spirometry.
Product CodeBZH
Regulation Number 868.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE
  SUBSTANTIALLY EQUIVALENT 2
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 10
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect measurement 22
Sticking 8
Total Device Problems 30

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