510(k) K151498

Breathing circuit bacterial/viral filter by Zhejiang Haisheng Medical Device Co., Ltd. — Product Code CAH

K151498 is an FDA 510(k) premarket notification submitted by Zhejiang Haisheng Medical Device Co., Ltd. for the device "Breathing circuit bacterial/viral filter". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Zhejiang Haisheng Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.