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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
FIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GANSHORN MEDIZIN ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIKRO OY
  SUBSTANTIALLY EQUIVALENT 1
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 1
VITALOGRAPH(IRELAND) LTD.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 1 1
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 1 1
Product Quality Problem 1 1
Break 1 1
Failure to Charge 1 1
Crack 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 1 1

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