510(k) K012264

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC by National Custom Ent., Inc. — Product Code DPS

K012264 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC". The FDA issued a decision of Substantially Equivalent on October 10, 2001. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.