510(k) K080602

AUDICOR SENSOR, MODELS: 2.0, 3.0 by Inovise Medical, Inc. — Product Code DRX

K080602 is an FDA 510(k) premarket notification submitted by Inovise Medical, Inc. for the device "AUDICOR SENSOR, MODELS: 2.0, 3.0". The FDA issued a decision of Substantially Equivalent on September 25, 2008. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Inovise Medical, Inc. has at least 10 other 510(k) clearances on record.