510(k) K890647

MEDILOG 9000-II AMBULATORY RECORDER by Oxford Medilog, Inc. — Product Code DSH

K890647 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "MEDILOG 9000-II AMBULATORY RECORDER". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.