K121257 is an FDA 510(k) clearance for the LARYNGEAL ELECTRODE. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on August 28, 2012, 124 days after receiving the submission on April 26, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K121257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2012 |
| Decision Date | August 28, 2012 |
| Days to Decision | 124 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 |