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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K240696
Device Name Airdog X8 Air Purifier (KJ800F-X8)
Applicant
Suzhou Beiang Smart Technology Co., Ltd.
175#, Songbei Rd., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Yan Zhang
Correspondent
Lexnovia Venture Studio , Ltd.
1f, # 10, Lane 10, Section 3, Zhongxiao E. Rd.
Da'An District
Taipei,  TW 106083
Correspondent Contact Chung Lun Chen
Regulation Number880.5045
Classification Product Code
FRF  
Date Received03/14/2024
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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