K083818 is an FDA 510(k) clearance for the UNIVERSAL ELECTRODES. 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 January 21, 2009, 30 days after receiving the submission on December 22, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K083818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2008 |
| Decision Date | January 21, 2009 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |