The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Neurosign V4 Intraoperative Nerve Monitor.
| Device ID | K203684 |
| 510k Number | K203684 |
| Device Name: | Neurosign V4 Intraoperative Nerve Monitor |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Magstim Company Ltd. Spring Gardens Whitland, GB Sa34 0hr |
| Contact | Rosie Hunt |
| Correspondent | Tom Campbell Magstim Company Ltd. Spring Gardens Whitland, GB Sa34 0hr |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-17 |
| Decision Date | 2021-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229532398 | K203684 | 000 |