The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim 3.0.
| Device ID | K083124 |
| 510k Number | K083124 |
| Device Name: | NIM 3.0 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Jayme Wilson |
| Correspondent | Jayme Wilson MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-02-27 |
| Summary: | summary |