# K100383: Vitaphone. Model 100 BT

- Pathway: 510(k) (Traditional)
- Applicant: Vitasystems GmbH
- Decided: Apr 20, 2010 after 63 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: 4 generations back to K963725 (1997). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053378: Loop Recorder  Vitaphone, 3100 Series, Tms Telemedizinische Systeme GmbH (2006) Summary page 1.
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 1.

## Most influential descendants
- K151013: Vitaphone Tele ECG Loop Recorder (2015), 0 descendants of its own

## Indications for use
Diagnostic evaluation of patients with asymptomnatic and symptomatic disturbances of the cardiac rhythm such as: - Dizziness - Heart race - Palpitations - Syncopes of unknown cause

Source page: https://510kreport.com/device/K100383
Methodology: https://510kreport.com/methodology