510(k) clearance

Peerbridge COR MDx (Cor MDx)

FDA 510(k) source

510(k) number

K253529

Applicant

Peerbridge Health, Inc.

Decision date

Sep 4, 2026

Date received

Nov 13, 2025

Decision

Substantially Equivalent

Clearance type

Abbreviated

Product code

MWJ

Device type

Electrocardiograph, Ambulatory (Without Analysis)

Device class

Class II

Regulation

21 CFR 870.2800

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

New York, NY, US