# K060374: Refa, Physiological Amplifier

- Pathway: 510(k) (Abbreviated)
- Applicant: Tms International BV
- Decided: May 30, 2006 after 106 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K172312: eego amplifiers (2018), 2 descendants of its own
- K243746: Delphi Amplifier (2025), 0 descendants of its own
- K201747: 8-CH Electroencephalography Amplifier (2020), 0 descendants of its own

## Indications for use
The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/ physiological research and exams. Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

Source page: https://510kreport.com/device/K060374
Methodology: https://510kreport.com/methodology