The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Neurosign 800, 8 Channel Motor Nerve Monitor.
| Device ID | K964869 |
| 510k Number | K964869 |
| Device Name: | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR |
| Classification | Stimulator, Nerve |
| Applicant | THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND Dyfed, Wales, GB Sa34 Ohr |
| Contact | C. Hovey |
| Correspondent | C. Hovey 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 | 1996-12-04 |
| Decision Date | 1997-05-14 |
| Summary: | summary |