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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)
Beiang Air Tech LTD.
175#, Songbei Road, Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Yan Zhang
Medical Wizdom, LLC
12F.-4, No. 81, Sec. 2, Chang'an E. Rd., Zhongshan Dist.
Taipei,  TW 10491
Correspondent Contact Tyra Chiu
Regulation Number880.5045
Classification Product Code
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