# K964836: Card Guard, Model CG-7100

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Jul 28, 1997 after 241 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.
100 later devices descend from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042254: PMP4 Selfcheck Ecg (2005), 99 descendants of its own
- K060911: CG-6108 Arrhythmia Ecg Event Recorder (2006), 44 descendants of its own
- K122184: Ecg Check (2013), 30 descendants of its own
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector (2007), 25 descendants of its own

## Indications for use
The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement. The CG-7100 is suggested to record and transmit ECG’s to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.

Source page: https://510kreport.com/device/K964836
Methodology: https://510kreport.com/methodology