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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K202766
Device Name EOS Air Cleaner
Applicant
Guangzhou Ajax Medical Equipment Co., Ltd.
Bldg. No 2 Dagang Industrial Zone, Shilou Town,Panyu,
District
Guangzhou,  CN 511447
Applicant Contact Atwood Lee
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park Guangzhou Economic &
Technology Deve
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number880.6500
Classification Product Code
FRA  
Date Received09/21/2020
Decision Date 06/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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