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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
ALERKAN LTD
  SUBSTANTIALLY EQUIVALENT 1
BENSON MEDICAL INSTRUMENTS CO.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH GERMANY 234 GMBH
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION GERMANY 234 GMBH
  SUBSTANTIALLY EQUIVALENT 4
CHEST M.I., INC.
  SUBSTANTIALLY EQUIVALENT 2
COHERO HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
COSMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ERESEARCH TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
ERESEARCHTECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
FEELLIFE HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
FIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GANSHORN MEDIZIN ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
INNOVISION A/S
  SUBSTANTIALLY EQUIVALENT 1
INOFAB SAGLIK TEKNOLOJILERI A.S
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INTERNATIONAL RESEARCH USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESPIRATORY DEVICES S.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDIKRO OY
  SUBSTANTIALLY EQUIVALENT 2
MEHOW INNOVATIVE LTD
  SUBSTANTIALLY EQUIVALENT 1
MIR MEDICAL INTERNATIONAL RESEARCH USA
  SUBSTANTIALLY EQUIVALENT 1
MIR MEDICAL INTL. RESEARCH SRL
  SUBSTANTIALLY EQUIVALENT 2
MONITORED THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MORGAN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC
  SUBSTANTIALLY EQUIVALENT 1
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 2
NDD MEDIZITECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
NUVOAIR AB
  SUBSTANTIALLY EQUIVALENT 2
PMD HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
PULMONARY FILTRATION TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
PULMONE ADVANCED MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PULMONX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUNDWORKS TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SAFEY MEDICAL DEVICES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SDI DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIASYS RESPIRATORY CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH (IRELAND) LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 3
VITALOGRAPH(IRELAND) LTD.
  SUBSTANTIALLY EQUIVALENT 4
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2017 1 1
2018 1 1
2019 1 1
2020 2 2
2021 1 1
2022 3 3
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 3 3
Crack 1 1
Break 1 1
Detachment of Device or Device Component 1 1
Unable to Obtain Readings 1 1
Electrical Shorting 1 1
Failure to Power Up 1 1
Device Emits Odor 1 1
Device Sensing Problem 1 1
Product Quality Problem 1 1
Defective Component 1 1
Premature Discharge of Battery 1 1
Electrical /Electronic Property Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Charge 1 1
Difficult to Open or Close 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 2 2
Insufficient Information 1 1
Dyspnea 1 1
Emotional Changes 1 1
No Consequences Or Impact To Patient 1 1

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