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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 K192971
Device Name Nebulizer Kit
Applicant
Excellentcare Medical (Huizhou) Ltd.
Shatou Industrial Zone. Yuanzhou Town.
Huizhou,  CN 516123
Applicant Contact Chunyu Zhao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
NO. 55 Shizhou middle road, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Elly Xu
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/23/2019
Decision Date 07/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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