# K060803: G.Usbamp

- Pathway: 510(k) (Traditional)
- Applicant: G.Tec Medical Engineering GmbH
- Decided: May 2, 2006 after 39 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
Longest line of descent: 2 generations back to K001564 (2000). 2 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023536: Nuamps, Neuroscan (2003) Summary page 1.

## Most influential descendants
- K090957: Blackrock Neuroport Biopotential Signal Processing System (2009), 13 descendants of its own
- K103140: Nicolet Wireless Eeg (2011), 7 descendants of its own
- K123255: g.HIamp (2012), 4 descendants of its own
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own
- K171669: g.Nautilus PRO (2017), 2 descendants of its own

## Indications for use
Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG.

Source page: https://510kreport.com/device/K060803
Methodology: https://510kreport.com/methodology