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TPLC
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show TPLC since
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Device
purifier, air, ultraviolet, medical
Product Code
FRA
Regulation Number
880.6500
Device Class
2
Premarket Reviews
Manufacturer
Decision
AEROBIOTIX, INC.
SUBSTANTIALLY EQUIVALENT
1
AEROCLEAN TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
AEROCLEAN TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
AERUS MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
AIRGLE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BLUEZONE PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
GENESIS AIR, INC.
SUBSTANTIALLY EQUIVALENT
1
GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
INVICTUS LIGHTING
SUBSTANTIALLY EQUIVALENT
1
MOLEKULE, INC.
SUBSTANTIALLY EQUIVALENT
3
SAMSUNG ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SYNEXIS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2021
1
1
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate Instructions for Non-Healthcare Professional
1
1
Device Sensing Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Device Difficult to Maintain
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
1
1
No Clinical Signs, Symptoms or Conditions
1
1
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