The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Pediguard Nerve Detector System.
| Device ID | K030526 |
| 510k Number | K030526 |
| Device Name: | PEDIGUARD NERVE DETECTOR SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta, GA 30319 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2004-12-29 |
| Summary: | summary |