510(k) K063268

CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 by Hsiner Co., Ltd. — Product Code BZD

K063268 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235". The FDA issued a decision of Substantially Equivalent on February 23, 2007. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.