ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS

Primary DI

07290008960250

Basic UDI-DI Code

B-07290008960250

Reference

E-430-0 to E-434-0, E-436-0, E-445-0

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

SHL Telemedicine International Ltd.

The CardioSenC is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’s integrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).