510(k) K821416

DISPOSABLE BLOOD PRESSURE TRANSDUCER by Bentley Laboratories, Inc. — Product Code DRS

K821416 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "DISPOSABLE BLOOD PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.