K945799 is an FDA 510(k) clearance for the NEUROSIGN 100 IMPEDANCE METER. 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 June 2, 1995, 186 days after receiving the submission on November 28, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K945799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1994 |
| Decision Date | June 02, 1995 |
| Days to Decision | 186 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 |