510(k) K202766

EOS Air Cleaner by Guangzhou Ajax Medical Equipment Co., Ltd. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2021
Date Received
September 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type