# K991307: Telemedicine 2000

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Jun 14, 1999 after 59 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
The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of ECG parameters of cardiac patients.

Source page: https://510kreport.com/device/K991307
Methodology: https://510kreport.com/methodology