K163547 is an FDA 510(k) clearance for the MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on April 11, 2017, 116 days after receiving the submission on December 16, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K163547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2016 |
| Decision Date | April 11, 2017 |
| Days to Decision | 116 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 |