510(k) K083256

ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 by K-Jump Health Co., Ltd. — Product Code CAF

K083256 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210". The FDA issued a decision of Substantially Equivalent on June 26, 2009. 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.