510(k) K001349

CARDIOVISE ECG INTERPRETATIVE SOFTWARE by Inovise Medical, Inc. — Product Code MWJ

K001349 is an FDA 510(k) premarket notification submitted by Inovise Medical, Inc. for the device "CARDIOVISE ECG INTERPRETATIVE SOFTWARE". The FDA issued a decision of Substantially Equivalent on July 27, 2000. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Inovise Medical, Inc. has at least 10 other 510(k) clearances on record.