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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 K250583
Device Name AdheResp Smart Breath-actuated Mesh Nebulizer
Applicant
Hcmed Innovations Co., Ltd.
Rm. B, 10f, # 319, Sec 2 Dunhua S. Rd.
Taipei City,  TW 10669
Applicant Contact Michelle Pieh
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/27/2025
Decision Date 06/20/2025
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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