510(k) K233864

ASSURE Wearable ECG by Kestra Medical Technologies, Inc. — Product Code MWJ

K233864 is an FDA 510(k) premarket notification submitted by Kestra Medical Technologies, Inc. for the device "ASSURE Wearable ECG". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800.