510(k) K112601

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER by Intricon Datrix Corporation — Product Code MWJ

K112601 is an FDA 510(k) premarket notification submitted by Intricon Datrix Corporation for the device "INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER". The FDA issued a decision of Substantially Equivalent on November 9, 2011. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Intricon Datrix Corporation has at least 1 other 510(k) clearance on record.