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TPLC
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show TPLC since
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Device
spirometer, diagnostic
Product Code
BZG
Regulation Number
868.1840
Device Class
2
Premarket Reviews
Manufacturer
Decision
CAREFUSION GERMANY 234 GMBH
SUBSTANTIALLY EQUIVALENT
1
COHERO HEALTH LLC
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
INOFAB SAGLIK TEKNOLOJILERI A.S
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
MONITORED THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MORGAN SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
2
NDD MEDIZINTECHNIK AG
SUBSTANTIALLY EQUIVALENT
2
NUVOAIR AB
SUBSTANTIALLY EQUIVALENT
2
PULMONE ADVANCED MEDICAL DEVICES, LTD.
SUBSTANTIALLY EQUIVALENT
1
PULMONX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ROUNDWORKS TECHNOLOGIES PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
SAFEY MEDICAL DEVICES PVT LTD
SUBSTANTIALLY EQUIVALENT
1
SDI DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
VITALOGRAPH (IRELAND) LTD.
SUBSTANTIALLY EQUIVALENT
1
VITALOGRAPH IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
3
VITALOGRAPH(IRELAND) LTD.
SUBSTANTIALLY EQUIVALENT
3
WELCH ALLYN, INC.
SUBSTANTIALLY EQUIVALENT
1
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
3
3
Failure to Power Up
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Sensing Problem
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Electrical Shorting
1
1
Detachment of Device or Device Component
1
1
Electrical /Electronic Property Problem
1
1
Premature Discharge of Battery
1
1
Failure to Charge
1
1
Crack
1
1
Smoking
1
1
Defective Component
1
1
Unable to Obtain Readings
1
1
Difficult to Open or Close
1
1
Break
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
Emotional Changes
1
1
Insufficient Information
1
1
Dyspnea
1
1
Cough
1
1
No Consequences Or Impact To Patient
1
1
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