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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 K211507
Device Name Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
Applicant
Beiang Air Tech , Ltd.
175#, Songbei Rd., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Yan Zhang
Correspondent
Medical Wizdom, LLC
12f.-4, # 81, Sec. 2, Chang'An E. Rd., Zhongshan Dist.
Taipei,  TW 10491
Correspondent Contact Tyra Chiu
Regulation Number880.5045
Classification Product Code
FRF  
Date Received05/14/2021
Decision Date 11/22/2022
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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