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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 K212395
Device Name Nebulizer
Applicant
Shenzhen Homed Medical Device Co., Ltd.
3rd Floor, Block 1, Longquan Industrial Zone,
Huarong Rd., Dalang St.
Shenzhen,  CN 518109
Applicant Contact Shi Shengming
Correspondent
Shenzhen Homed Medical Device Co., Ltd.
3rd Floor, Block 1, Longquan Industrial Zone,
Huarong Rd., Dalang St.
Shenzhen,  CN 518109
Correspondent Contact Shi Shengming
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/02/2021
Decision Date 03/25/2022
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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