# K052556: CG-7000DX-BT Ecg Recorder/Transmitter

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Jan 9, 2006 after 115 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: 2 generations back to K942704 (1994). 2 ancestors in all.
24 later devices descend from it; 4 cite 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)
- K993799: CG-7000DX Ecg Recorder/Transmitter, Card Guard Scientific Survival, Ltd. (1999) Summary page 2.

## Most influential descendants
- 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
- K171942: Electrocardiograph (2018), 3 descendants of its own

## Indications for use
12-Lead electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, incorporates recording/ 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 remote hand held device/PC/printer for viewing and processing.

Source page: https://510kreport.com/device/K052556
Methodology: https://510kreport.com/methodology