510(k) K982651

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER by Corometrics Medical Systems, Inc. — Product Code HEL

K982651 is an FDA 510(k) premarket notification submitted by Corometrics Medical Systems, Inc. for the device "COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Corometrics Medical Systems, Inc. has at least 4 other 510(k) clearances on record.