# K982034: E-Fax System

- Pathway: 510(k) (Traditional)
- Applicant: Blakbag, Ltd., Division of Coherent Systems
- Decided: Feb 19, 1999 after 254 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: 1 generation back to K880283 (1988). 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)
- K880283: Paceart Pacemaker Patient Test Syst/Tel Opt CPTS, Paceart, Inc. (1988) Summary page 1.
- K931296: Paceart Cardiophone, Paceart, Inc. (1993) Summary page 1.
- K952065: Paceart Cardiovoice, Paceart, Inc. (1996) Summary page 1.

## Indications for use
The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician.

Source page: https://510kreport.com/device/K982034
Methodology: https://510kreport.com/methodology