K123255 is an FDA 510(k) clearance for the g.HIamp. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on December 20, 2012, 63 days after receiving the submission on October 18, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K123255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWL — Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |