K071349 is an FDA 510(k) clearance for the NEUROSIGN LARYNGEAL ELECTRODES. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by The Magstim Company , Ltd. (Carmarthenshire, GB). The FDA issued a Cleared decision on December 12, 2007, 212 days after receiving the submission on May 14, 2007.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K071349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2007 |
| Decision Date | December 12, 2007 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |