510(k) K082009

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS by Hsiner Co., Ltd. — Product Code CAF

K082009 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS". The FDA issued a decision of Substantially Equivalent on August 22, 2008. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.