# K080047: Cardiosen'c

- Pathway: 510(k) (Traditional)
- Applicant: Shl Telemedicine International, Ltd.
- Decided: Jul 11, 2008 after 185 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 11 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002310: Cardiobeeper CB12/12, Model CB12/12, Meridian Medical Technologies, Ltd. (2000) Summary page 2.
- K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter, Shl Telemedicine International, Ltd. (2007) Summary page 2.

## Most influential descendants
- K113514: Smartheart (2012), 10 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K180157: QT ECG (2018), 2 descendants of its own

## Indications for use
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.

Source page: https://510kreport.com/device/K080047
Methodology: https://510kreport.com/methodology