K162460 is an FDA 510(k) clearance for the WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Wavi Co. (Englewood, US). The FDA issued a Cleared decision on April 28, 2017, 238 days after receiving the submission on September 2, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K162460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |