# K092853: 3 Channel Digital Ambulatory Ecg Recorder Model Galix Gbi-3SM

- Pathway: 510(k) (Traditional)
- Applicant: Galix Biomedical Instrumentation, Inc.
- Decided: Jul 9, 2010 after 296 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- 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
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 primary use of ambulatory monitoring are listed below. 1- Evaluation of suspected of known cardiac rhythm disorders. 2 - Evaluation of symptoms suggestive of an arrhythmia disorder. 3 - Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death. 4 - Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense. 5 - Evaluation of chest pain. 6 - Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment. 7 - The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Bolter Recorder. However the unit has the ability to record Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software. Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

Source page: https://510kreport.com/device/K092853
Methodology: https://510kreport.com/methodology