510(k) K253529

Peerbridge COR MDx (Cor MDx) by Peerbridge Health, Inc. — Product Code MWJ

K253529 is an FDA 510(k) premarket notification submitted by Peerbridge Health, Inc. for the device "Peerbridge COR MDx (Cor MDx)". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Peerbridge Health, Inc. has at least 1 other 510(k) clearance on record.