510(k) K121520

ULTRASONIC NEBULIZER (MESH TYPE) by K-Jump Health Co., Ltd. — Product Code CAF

K121520 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "ULTRASONIC NEBULIZER (MESH TYPE)". The FDA issued a decision of Substantially Equivalent on March 15, 2013. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. K-Jump Health Co., Ltd. has at least 10 other 510(k) clearances on record.