# K151013: Vitaphone Tele ECG Loop Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Vitasystems GmbH
- Decided: Apr 30, 2015 after 15 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: 5 generations back to K963725 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100383: Vitaphone. Model 100 BT, Vitasystems GmbH (2010) Summary page 4.

## Indications for use
Diagnostic evaluation of patients w ith asymptomatic and symptomatic disturbances of cardiac rhythm such as: -Dizziness -Heart race -Palpitation -Syncopes of unknown cause

Source page: https://510kreport.com/device/K151013
Methodology: https://510kreport.com/methodology