# K983026: Pacemaker Data PMD Transmitter, Model CG-4000

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 2, 1998 after 93 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
This device is intended to assist doctors in checking implanted pacing systems of ambulatory patients. The device transmits the patient's ECG signals, including pacemaker pulse width code, to the remote receiving station via the telephone line.

Source page: https://510kreport.com/device/K983026
Methodology: https://510kreport.com/methodology