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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 K254171
Device Name Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
Applicant
Shenzhen Mericonn Technology Co., Ltd.
3/F, Bldg. 2, Tiantong Industrial Park, Gaofeng Community
Dalang St., Longhua District
Shenzhen,  CN 518109
Applicant Contact Chuanyuan Jiang
Correspondent
Chonconn Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/23/2025
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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