510(k) K100266

ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 by Camntech, Ltd. — Product Code MWJ

K100266 is an FDA 510(k) premarket notification submitted by Camntech, Ltd. for the device "ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603". The FDA issued a decision of Substantially Equivalent on April 29, 2010. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Camntech, Ltd. has at least 1 other 510(k) clearance on record.