# K051163: Galix Ecg Professional Station

- Pathway: 510(k) (Traditional)
- Applicant: Galix Biomedical Instrumentation, Inc.
- Decided: Jan 31, 2006 after 271 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use: - with Male/Female Pediatric to Adult population in Hospital, Clinic and Physician's office - under prescription by a physician

Source page: https://510kreport.com/device/K051163
Methodology: https://510kreport.com/methodology