# K991211: Eventstation Ecg Trans-Telephonic Receiving System

- Pathway: 510(k) (Traditional)
- Applicant: Reynolds Medical, Ltd.
- Decided: Jul 8, 1999 after 90 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 K923930 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972649: Cardiocall Cardiac Event Recorder, Reynolds Medical, Ltd. (1997) Summary page 1.
- K952065: Paceart Cardiovoice, Paceart, Inc. (1996) Summary page 1.

## Indications for use
The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic “Unattended Mode” or a manual “Attended Mode.” It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

Source page: https://510kreport.com/device/K991211
Methodology: https://510kreport.com/methodology