510(k) K070014

AUTO DETECT FOR TELAHEART DR200/E-A by North East Monitoring, Inc. — Product Code MWJ

K070014 is an FDA 510(k) premarket notification submitted by North East Monitoring, Inc. for the device "AUTO DETECT FOR TELAHEART DR200/E-A". The FDA issued a decision of Substantially Equivalent on May 25, 2007. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. North East Monitoring, Inc. has at least 9 other 510(k) clearances on record.