K130346 is an FDA 510(k) clearance for the SYNERGY FOCUS DESKTOP VERSION. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on May 2, 2013, 80 days after receiving the submission on February 11, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K130346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2013 |
| Decision Date | May 02, 2013 |
| Days to Decision | 80 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |