K053141 is an FDA 510(k) clearance for the NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by The Magstim Company , Ltd. (Whitland, Dyfed Wales, GB). The FDA issued a Cleared decision on December 14, 2005, 35 days after receiving the submission on November 9, 2005.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K053141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2005 |
| Decision Date | December 14, 2005 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |