K923056 is an FDA 510(k) clearance for the NEUROSIGN MODEL 100. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by The Magstim Company , Ltd. (Carmarthenshire, GB). The FDA issued a Cleared decision on November 24, 1992, 153 days after receiving the submission on June 24, 1992.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K923056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1992 |
| Decision Date | November 24, 1992 |
| Days to Decision | 153 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 |