K991583 is an FDA 510(k) clearance for the NEUROSIGN 400, 4 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. (New York, US). The FDA issued a Cleared decision on May 19, 1999, 12 days after receiving the submission on May 7, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K991583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1999 |
| Decision Date | May 19, 1999 |
| Days to Decision | 12 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 |