510(k) K021470

SEER LIGHT COMPACT DIGITAL HOLTER RECORDER by General Electric Medical Systems Information Techn — Product Code MWJ

K021470 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "SEER LIGHT COMPACT DIGITAL HOLTER RECORDER". The FDA issued a decision of Substantially Equivalent on November 14, 2002. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.