# K982228: FM Demodulator-4 Lead Model #8500-05 and FM Demodulator-12 Lead Model # 8500-25

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: Jan 14, 1999 after 203 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 TZ Medical “FM Demodulator” (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces. The device is used with ECG machines which do not have built in "translators™".

Source page: https://510kreport.com/device/K982228
Methodology: https://510kreport.com/methodology