K140400 is an FDA 510(k) clearance for the ES2 NEUROMONITORING ACCESSORY INSTRUMENTS. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 1, 2014, 133 days after receiving the submission on February 18, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K140400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | July 01, 2014 |
| Days to Decision | 133 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 |