510(k) K872497

MODEL MR-45 AMBULATORY HOLTER MONITOR by Oxford Medilog, Inc. — Product Code DSI

K872497 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "MODEL MR-45 AMBULATORY HOLTER MONITOR". The FDA issued a decision of Substantially Equivalent on October 6, 1987. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.