K060803 is an FDA 510(k) clearance for the G.USBAMP. 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 May 2, 2006, 39 days after receiving the submission on March 24, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K060803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2006 |
| Decision Date | May 02, 2006 |
| Days to Decision | 39 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 |