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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
CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOSTAR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KNOX MEDICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SONMOL MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIAN DALU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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