# K993799: CG-7000DX Ecg Recorder/Transmitter

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 10, 1999 after 31 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 K942704 (1994). 1 ancestor in all.
25 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942704: Card Guard, Model CG-7000D Ecg Recorder/Transmitter, Card Guard Scientific Survival, Ltd. (1994) Summary page 2.

## Most influential descendants
- K052556: CG-7000DX-BT Ecg Recorder/Transmitter (2006), 24 descendants of its own
- K131819: PC ECG (2013), 12 descendants of its own
- K152427: PC ECG (2016), 11 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own
- K082077: BT3/6, BT12 (2008), 6 descendants of its own

## Indications for use
CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional: a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist. b. The ECG is recorded and transferred to a PC for viewing and processing. The Universal IR Adapter is used for conveying data to the remote receiving station or PC.

Source page: https://510kreport.com/device/K993799
Methodology: https://510kreport.com/methodology