K072016 is an FDA 510(k) clearance for the CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on October 19, 2007, 88 days after receiving the submission on July 23, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K072016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2007 |
| Decision Date | October 19, 2007 |
| Days to Decision | 88 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 |