# K111180: Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel Miniature Ambulatory

- Pathway: 510(k) (Special)
- Applicant: Vasomedical, Inc.
- Decided: Jun 28, 2011 after 62 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K943862 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C, Vasomedical, Inc. (2009) Summary page 1.

## Indications for use
Vasomedical-Biox 12 - Channel Ambulatory EGG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel EGG signals from the upper body surfaces. Cardiac Rhythm is acquired via EGG signals. Vasomedical-Biox 3 - Channel Miniature Ambulatory EGG Bolter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel EGG signals from the upper body surfaces. Cardiac rhythm is also acquired via EGG signals. The Bolter Recorders are intended for adults and children who are over the age of six years. The Models 1304 and 1303 work with the GB Series EGG Analysis Software which has been previously cleared under (k083820) "The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications".. The system is only for measurement, recording and display. It makes no diagnosis.

Source page: https://510kreport.com/device/K111180
Methodology: https://510kreport.com/methodology