Cardiovascular · 510(k) · 2017
Peerbridge Cor(TM) System
Peerbridge Health INc.. Cleared by FDA on 27 September 2017 under submission K171936, product code DSH (recorder, magnetic tape, medical). What FDA's record says, in FDA's words.
Device record · K171936
- Device. Peerbridge Cor(TM) SystemDEVICE
- Company. Peerbridge Health INc.COMPANY
- Decision. 27 September 2017, 510(k), substantially equivalent (traditional review); received 28 June 2017DECISION
- Panel. CardiovascularPANEL
- Product code. DSH, Recorder, Magnetic Tape, MedicalCODE
- Regulation. 21 CFR 870.2800, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
[807.92(a)(5)] The Peerbridge Cor System family of products is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge Cor System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre- syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 972 reports filed against devices carrying product code DSH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
11 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00193
Alleged burn was initially reported on (b)(6) 2026. Patient was unable to specify whether they believed the issue was caused by the sensor or the patch, but stated the sensor was not hot. Patient was sitting and watching tv at the time of occurrence. Additional information was received on 14 August 2026 via GFE response. Patient was still unable to clarify whether they believed the burn to be from the sensor overheating or the patch. Patient described their symptoms as itchy chemical burns. […]
11 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00194
On (b)(6) 2026 the patient called to report skin irritation from an ePatch used with Universal Patch configuration (Lot #E651128). The patient described the irritation as a painful raised skin chemical burn, characterized as a severe burn with a hole and discharge. Additional symptoms included burning sensation, itching, rash, bleeding/discharge, open sores, and rawness of the skin. Additional information was received on 17 August 2026 via GFE response. Patient stated they believed the burn […]
4 September 2026 · Injury · CAM System · BARDY DIAGNOSTICS, INC. · report 3014226707-2026-00011
4 September 2026 · Injury · CAM System · BARDY DIAGNOSTICS, INC. · report 3014226707-2026-00010
2 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00190
On (b)(6) 2026 the patient reported experiencing a rash which they described as a "3rd degree burn" that oozes while wearing the ePatch Sensor - 2.5 utilizing the Electrode - Patch - Universal 2 Channel configuration. The patient's symptoms were categorized as burning sensation, rash, bleeding with discharge, and rawness and open skin. The patient did not seek medical treatment for the skin irritation. The patient confirmed following the recommended skin preparation steps and has no history of […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DSH, in Cardiovascular, or cleared in 2017. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.