510(k) K841960

CARDIO METRICS INVASIVE PRESSURE MONIT by Sterile Design, Inc. — Product Code DRS

K841960 is an FDA 510(k) premarket notification submitted by Sterile Design, Inc. for the device "CARDIO METRICS INVASIVE PRESSURE MONIT". The FDA issued a decision of Substantially Equivalent on November 8, 1985. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Sterile Design, Inc. has at least 9 other 510(k) clearances on record.