510(k) K182548

Accucuff Cuff Pressure Indicator by Tianjin Medis Medical Device Co., Ltd. — Product Code BSK

K182548 is an FDA 510(k) premarket notification submitted by Tianjin Medis Medical Device Co., Ltd. for the device "Accucuff Cuff Pressure Indicator". The FDA issued a decision of Substantially Equivalent on January 25, 2019. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Tianjin Medis Medical Device Co., Ltd. has at least 2 other 510(k) clearances on record.