# K031229: Telzuit Cardiac Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Telzuit Technologies, Inc.
- Decided: Jul 9, 2003 after 82 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 K813101 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003707: Cardionet Ambulatory Ecg Monitor, Model CN1000A, Cardionet (2001) Summary page 1.
- K965101: Cardiobeeper CB-12L, Meridian Medical Technologies, Inc. (1997) Summary page 1.

## Indications for use
The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via cellular telephone to a remotely located ECG analysis station for evaluation by a medical professional.

Source page: https://510kreport.com/device/K031229
Methodology: https://510kreport.com/methodology