The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Neuro Vision System.
| Device ID | K090298 |
| 510k Number | K090298 |
| Device Name: | NUVASIVE NEURO VISION SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Han Fan |
| Correspondent | Han Fan NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-06-08 |
| Summary: | summary |