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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 K244035
Device Name Portable mesh nebulizer (JM821)
Applicant
Shenzhen Jermei Medical Device Technology Co., Ltd.
Rm201, 202, 4th Bldg. Xianyuxing Company, 4th Bldg. Xianyuxi
Industrial Zn,Yuhe Rd.,Gonghe Community,Shajing St.,Baoan Ds
Shenzhen,  CN 518000
Applicant Contact Fang Li
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A
Zhongguan Times Square Nanshan District
Shenzhen,  CN 518000
Correspondent Contact James Tsai
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/30/2024
Decision Date 09/19/2025
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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