# K992706: Galix Gbi -3S-LP

- Pathway: 510(k) (Traditional)
- Applicant: Galix Biomedical Instrumentation, Inc.
- Decided: Mar 15, 2001 after 581 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 Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of 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/K992706
Methodology: https://510kreport.com/methodology