The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim Vital, Nerve Integrity Monitor.
| Device ID | K200759 |
| 510k Number | K200759 |
| Device Name: | NIM Vital, Nerve Integrity Monitor |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 -0980 |
| Contact | Marek Pawlowski |
| Correspondent | Marek Pawlowski Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 -0980 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2020-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000112479 | K200759 | 000 |
| 00763000395896 | K200759 | 000 |
| 00763000395902 | K200759 | 000 |
| 00763000003005 | K200759 | 000 |
| 00763000002992 | K200759 | 000 |
| 00763000528584 | K200759 | 000 |
| 00763000528577 | K200759 | 000 |