# K101703: Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model FG-00084

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Jul 13, 2010 after 26 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 15 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector, Card Guard Scientific Survival, Ltd. (2008) Summary page 1.

## Most influential descendants
- K110499: CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector (2011), 2 descendants of its own
- K143359: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (2015), 1 descendant of its own
- K170565: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (2017), 0 descendants of its own

## Indications for use
The CG-6 108 ACT-3L Continuous ECG Monitor and Arrhythmnia Detector is.intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient EGG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evalu ati on.

Source page: https://510kreport.com/device/K101703
Methodology: https://510kreport.com/methodology