510(k) K043454

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 by Medicomp, Inc. — Product Code MLO

K043454 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410". The FDA issued a decision of Substantially Equivalent on March 24, 2005. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Medicomp, Inc. has at least 10 other 510(k) clearances on record.