The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Neurosign Model 100.
| Device ID | K923056 |
| 510k Number | K923056 |
| Device Name: | NEUROSIGN MODEL 100 |
| Classification | Stimulator, Nerve |
| Applicant | THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND Dyfed, Wales, GB Sa34 Ohr |
| Contact | R. W Lewis |
| Correspondent | R. W Lewis THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND Dyfed, Wales, GB Sa34 Ohr |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-24 |
| Decision Date | 1992-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925023574 | K923056 | 000 |
| 05060229530943 | K923056 | 000 |
| 05060229530356 | K923056 | 000 |