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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 K161586
Device Name The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
Applicant
Shenzhen Homed Medical Device Co., Ltd.
#2 Bldg., Longgu Industrial Zone, Longhua Town
Shenzhen,  CN 518109
Applicant Contact Shengming Shi
Correspondent
Shenzhen Homed Medical Device Co., Ltd.
#2 Bldg., Longgu Industrial Zone, Longhua Town
Shenzhen,  CN 518109
Correspondent Contact Shengming Shi
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/08/2016
Decision Date 09/06/2017
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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