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TPLC
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show TPLC since
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Device
spirometer, diagnostic
Regulation Description
Diagnostic spirometer.
Product Code
BZG
Regulation Number
868.1840
Device Class
2
Premarket Reviews
Manufacturer
Decision
FEELLIFE HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
GOSTAR CO., LTD
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
1
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
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
1
1
2022
3
3
2023
2
2
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
3
3
Electrical Shorting
1
1
Electrical /Electronic Property Problem
1
1
Difficult to Open or Close
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Detachment of Device or Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
Insufficient Information
2
2
Dyspnea
1
1
Cough
1
1
Emotional Changes
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Nov-07-2024
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