510(k) K120462

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) by Inovise Medical, Inc. — Product Code MLO

K120462 is an FDA 510(k) premarket notification submitted by Inovise Medical, Inc. for the device "AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Inovise Medical, Inc. has at least 10 other 510(k) clearances on record.