K964869 is an FDA 510(k) clearance for the NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR. 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 May 14, 1997, 161 days after receiving the submission on December 4, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K964869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1996 |
| Decision Date | May 14, 1997 |
| Days to Decision | 161 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 |