510(k) K851517

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO by Circadian, Inc. — Product Code DSI

K851517 is an FDA 510(k) premarket notification submitted by Circadian, Inc. for the device "CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO". The FDA issued a decision of Substantially Equivalent on October 2, 1985. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Circadian, Inc. has at least 10 other 510(k) clearances on record.