DeviceClearance

Peerbridge COR MDx (Cor MDx)— 510(k) K253529

Substantially Equivalent

Peerbridge Health, Inc.

FDA 510(k) clearance K253529 for Peerbridge COR MDx (Cor MDx), Substantially Equivalent on 2026-09-04. Applicant: Peerbridge Health, Inc.. Device class: 2.

Summary

Peerbridge Health's COR MDx is filed under MWJ, ambulatory electrocardiographs without analysis. The record doesn't describe its recording duration or form factor.

Class II, 21 CFR 870.2800. Cardiovascular is both the classification panel and the review panel. It came in as an Abbreviated 510(k).

Peerbridge filed from New York, New York. The decision came 295 calendar days after receipt (November 13, 2025 to September 4, 2026).

Clearance details

Applicant
Peerbridge Health, Inc.
Product code
Product code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.