K230320 is an FDA 510(k) clearance for the NIM Standard Reinforced 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 October 26, 2023, 262 days after receiving the submission on February 6, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K230320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2023 |
| Decision Date | October 26, 2023 |
| Days to Decision | 262 days |
| Submission Type | Special |
| 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 |