The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800.
| Device ID | K053141 |
| 510k Number | K053141 |
| Device Name: | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 |
| Classification | Stimulator, Nerve |
| Applicant | THE MAGSTIM COMPANY LTD. SPRING GARDENS Whitland, Dyfed Wales, GB Sa34 Ohr |
| Contact | Chris Lewis |
| Correspondent | Chris 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-09 |
| Decision Date | 2005-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229530974 | K053141 | 000 |
| 05060229530318 | K053141 | 000 |
| 05060229530301 | K053141 | 000 |
| 05060229530141 | K053141 | 000 |
| 05060229530103 | K053141 | 000 |
| 05060229530004 | K053141 | 000 |