K121816 is an FDA 510(k) clearance for the SENSUS ELECTRODE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Neurometrix, Inc. (Waltham, US). The FDA issued a Cleared decision on November 26, 2012, 159 days after receiving the submission on June 20, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K121816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2012 |
| Decision Date | November 26, 2012 |
| Days to Decision | 159 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 |