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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
ERESEARCHTECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
FEELLIFE HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
INOFAB SAGLIK TEKNOLOJILERI A.S
  SUBSTANTIALLY EQUIVALENT 1
MEHOW INNOVATIVE LTD
  SUBSTANTIALLY EQUIVALENT 1
MIR MEDICAL INTERNATIONAL RESEARCH USA
  SUBSTANTIALLY EQUIVALENT 1
MONITORED THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORGAN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
NUVOAIR AB
  SUBSTANTIALLY EQUIVALENT 2
ROUNDWORKS TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SAFEY MEDICAL DEVICES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 3
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 1 1
2022 3 3
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 3 3
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1
Difficult to Open or Close 1 1
Smoking 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Emotional Changes 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
Dyspnea 1 1
Cough 1 1

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