510(k) K161586

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) by Shenzhen Homed Medical Device Co., Ltd. — Product Code CAF

K161586 is an FDA 510(k) premarket notification submitted by Shenzhen Homed Medical Device Co., Ltd. for the device "The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)". The FDA issued a decision of Substantially Equivalent on September 6, 2017. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Shenzhen Homed Medical Device Co., Ltd. has at least 3 other 510(k) clearances on record.