# K003220: Personal Ecg Transmitter, Model CG-6550

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Nov 8, 2000 after 23 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
No predicates in its family tree.
45 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K060911: CG-6108 Arrhythmia Ecg Event Recorder (2006), 44 descendants of its own
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector (2007), 25 descendants of its own
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector (2008), 18 descendants of its own
- K083535: Heartrak Smart Ecat (2008), 17 descendants of its own
- K131699: Emotion Ecg Mobile (2013), 16 descendants of its own

Source page: https://510kreport.com/device/K003220
Methodology: https://510kreport.com/methodology