peerbridgehealth.comPeerbridge Cor(TM) System
Peerbridge Health INc.
PEERBRIDGE HEALTH, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014111150 | 3014111150 | PEERBRIDGE HEALTH, INC. | 1 | N | 2026-01-01 | 1000 Corporate Centre Dr Ste 390 Franklin TN US 37067 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B608COREVENT0 | Peerbridge Cor System - "COREVENTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT (""Cor XT"") and the Peerbridge Cor™ Event (""Cor Event""). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor Event is configured for the following:- 24 hours of Holter monitoring - Patient Activated Event with Surveillance" | 7736778886 | c.pillar@peerbridgehealth.com |
| B608CORXT0 | Peerbridge Cor System - "CORXTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT (""Cor XT"") and the Peerbridge Cor™ Event (""Cor Event""). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor XT is configured for the following:- 24 hours of Holter monitoring and- Up to 7 days of Holter Monitoring" | 7736778886 | c.pillar@peerbridgehealth.com |
| B608CORXT1 | Peerbridge Cor System - CORXT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor XT is configured for the following: - 24 hours of Holter monitoring and - Up to 7 days of Holter Monitoring | 7736778886 | c.pillar@peerbridgehealth.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 212100 | 1058840137 | K171936 | Peerbridge Cor(TM) System | DSH | 2017-09-27 |
| 212100 | 1392856763 | ||||
| 212100 | 1393977603 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DSH | 1 | 2017-09-27 |
PMN#
GUDID#
Peerbridge Cor System - "COREVENTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT (""Cor XT"") and the Peerbridge Cor™ Event (""Cor Event""). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor Event is configured for the following:- 24 hours of Holter monitoring - Patient Activated Event with Surveillance"
2018-02-06
Peerbridge Cor System - "CORXTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT (""Cor XT"") and the Peerbridge Cor™ Event (""Cor Event""). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor XT is configured for the following:- 24 hours of Holter monitoring and- Up to 7 days of Holter Monitoring"
2018-02-12
Peerbridge Cor System - CORXT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor XT is configured for the following: - 24 hours of Holter monitoring and - Up to 7 days of Holter Monitoring
2018-02-12