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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K202171
Device Name Pulmogine Vibrating Mesh Nebulizer
Applicant
Hcmed Innovations Co., Ltd.
Rm.B, 10f, #319, Sec.2, Dunhua S. Rd., Da-An District,
Taipei City,  TW 10669
Applicant Contact Yiling Lee
Correspondent
Hcmed Innovations Co., Ltd.
Rm.B, 10f, #319, Sec.2, Dunhua S. Rd., Da-An District,
Taipei City,  TW 10669
Correspondent Contact Yiling Lee
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/03/2020
Decision Date 07/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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