K130136 is an FDA 510(k) clearance for the DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on July 19, 2013, 182 days after receiving the submission on January 18, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K130136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2013 |
| Decision Date | July 19, 2013 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |