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FDA 510(k)

Peerbridge Cor(TM) System

K-Number: K171936 · 2017-09-27

ApplicantPeerbridge Health, Inc.
Decision Date2017-09-27
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peerbridge Cor(TM) System 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 2017-09-27 under 510(k) number K171936. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peerbridge Cor(TM) System?

Peerbridge Cor(TM) System is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Peerbridge Health, Inc.. The 510(k) number is K171936.

When did Peerbridge Cor(TM) System receive FDA 510(k) clearance?

Peerbridge Cor(TM) System received FDA 510(k) clearance on 2017-09-27, under 510(k) number K171936.

Who is the listed applicant for Peerbridge Cor(TM) System?

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(TM) System?

The FDA product code for Peerbridge Cor(TM) System is DSH.

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

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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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