510(k) K133014

DMS 300-2W HOLTER ECG RECORDER by Diagnostic Monitoring Software — Product Code MWJ

K133014 is an FDA 510(k) premarket notification submitted by Diagnostic Monitoring Software for the device "DMS 300-2W HOLTER ECG RECORDER". The FDA issued a decision of Substantially Equivalent on May 19, 2014. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Diagnostic Monitoring Software has at least 4 other 510(k) clearances on record.