Lifesignals, Inc.

Address:426 South Hillview Drive,Milpitas,CA,95035,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (10) Electrocardiograph, Ambulatory (Without Analysis) (MWJ) (6) Electrode, Electrocardiograph (DRX) (4) Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (4) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1)

Premarket Exempt

Clear

Advance Biometrix - B353AB12511 Catalog Number : AB1251_US

Device Description : Wearable Biosensor - ECG Remote Monitoring Biosensor

Device Class :

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, MWJ

Prescription Use : Yes

Device Count : 1

Advance Biometrix - B353AB12571 Catalog Number : AB1257_US

Device Description : Wearable Biosensor - ECG Remote Monitoring Biosensor

Device Class :

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, MWJ

Prescription Use : Yes

Device Count : 1

Cherish Serenity - B353CS124501 Catalog Number :

Device Description : Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

Device Class :

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRT, DRG, DRX

Prescription Use : Yes

Device Count : 1

CORVITALS - B353CV12451 Catalog Number :

Device Description : Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

Device Class :

Duns Number: 798830720

Premarket Exempt : No

Product Code : MWJ, DRG

Prescription Use : Yes

Device Count : 1

CorVitals - B353CV12531 Catalog Number : CV1253_US

Device Description : Wearable Biosensor - ECG Remote Monitoring Biosensor Patch

Device Class :

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, MWJ, MHX

Prescription Use : Yes

Device Count : 1

ImagineMIC - B353IM11101 Catalog Number :

Device Description : Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

Device Class : 2

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, DRX, DRT

Prescription Use : Yes

Device Count : 1

ImagineMed - B353IM12101 Catalog Number :

Device Description : Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

Device Class : 2

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, DRX, DRT

Prescription Use : Yes

Device Count : 1

HOLTER CONNECT - B353LA1252C1 Catalog Number :

Device Description : HOLTER CONNECT business logic is a software running on cloud platform that provi HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician.

Device Class : 2

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, MWJ

Prescription Use : Yes

Device Count : 1

HOLTER CONNECT - B353LA1252R1 Catalog Number :

Device Description : HOLTER CONNECT Relay Application is a software that is installed on a compatible HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.

Device Class : 2

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRG, MWJ

Prescription Use : Yes

Device Count : 1

LifeSignal - B353LP11101 Catalog Number :

Device Description : Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

Device Class : 2

Duns Number: 798830720

Premarket Exempt : No

Product Code : DRT, DRG, DRX

Prescription Use : Yes

Device Count : 1

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