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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spirometer, diagnostic
Regulation Description Diagnostic spirometer.
Product CodeBZG
Regulation Number 868.1840
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
ERESEARCH TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
FIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GANSHORN MEDIZIN ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K160116  SpiroScout
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESPIRATORY DEVICES S.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDIKRO OY
  SUBSTANTIALLY EQUIVALENT 2
MEDISOFT S.A.
  SUBSTANTIALLY EQUIVALENT 1
MONITORED THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NDD MEDIZITECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
PULMONE ADVANCED MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SDI DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH(IRELAND) LTD.
  SUBSTANTIALLY EQUIVALENT 3
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Smoking 1
Total Device Problems 1


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