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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 K182906
Device Name Portable Mesh Nebulizer
Applicant
Feellife Health, Inc.
Rm. 1903, Bldg. A, #9 Furong Rd., Tantou Bao'An
District
Shenzhen,  CN 518104
Applicant Contact Owen Zhang
Correspondent
Medwheat (Shanghai) Medical Technology Co. , Ltd.
Yangpu District Liaoyuan E. Rd. Shuangyang First Suite
#33 Rm. 303
Shanghai,  CN 200082
Correspondent Contact Jonathan Hu
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/17/2018
Decision Date 09/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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