K112686 is an FDA 510(k) clearance for the NEXT GEN EMG ENDOTRACHEAL TUBE. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 27, 2012, 286 days after receiving the submission on September 15, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K112686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2011 |
| Decision Date | June 27, 2012 |
| Days to Decision | 286 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 |