K233001 is an FDA 510(k) clearance for the Bioscope Neuromonitor Device. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Biosys Biyomedikal Muhendislik San. VE Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on December 13, 2024, 448 days after receiving the submission on September 22, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K233001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | December 13, 2024 |
| Days to Decision | 448 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 |