# K994009: CG-2100 Ecg Transmitter

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 21, 1999 after 25 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: 1 generation back to K963725 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified), Card Guard, Ltd. (1997) Summary page 3.

## Indications for use
The device is intended for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is not intended for simultaneous recording and transmitting of the patient ECG signals.

Source page: https://510kreport.com/device/K994009
Methodology: https://510kreport.com/methodology