K094054 is an FDA 510(k) clearance for the MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on May 14, 2010, 134 days after receiving the submission on December 31, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K094054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2009 |
| Decision Date | May 14, 2010 |
| Days to Decision | 134 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |