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FDA 510(k)

Peerbridge COR MDx (Cor MDx)

K-Number: K253529 · 2026-09-04

ApplicantPeerbridge Health, Inc.
Decision Date2026-09-04
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peerbridge COR MDx (Cor MDx) is the device name listed in this FDA 510(k) record. The listed applicant is Peerbridge Health, Inc.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K253529. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peerbridge COR MDx (Cor MDx)?

Peerbridge COR MDx (Cor MDx) is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Peerbridge Health, Inc.. The 510(k) number is K253529.

When did Peerbridge COR MDx (Cor MDx) receive FDA 510(k) clearance?

Peerbridge COR MDx (Cor MDx) received FDA 510(k) clearance on 2026-09-04, under 510(k) number K253529.

Who is the listed applicant for Peerbridge COR MDx (Cor MDx)?

The FDA 510(k) record lists Peerbridge Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peerbridge COR MDx (Cor MDx)?

The FDA product code for Peerbridge COR MDx (Cor MDx) is MWJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITINGNCT07775976Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care PathwaysENROLLING_BY_INVITATION

Other records listing Peerbridge Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171936Peerbridge Cor(TM) System

Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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