510(k) K041901

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER by North East Monitoring, Inc. — Product Code MWJ

K041901 is an FDA 510(k) premarket notification submitted by North East Monitoring, Inc. for the device "SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER". The FDA issued a decision of Substantially Equivalent on August 31, 2004. 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.