The following data is part of a premarket notification filed by Xavant Technology (pty), Ltd. with the FDA for Xpod/xmap Nerve Stimulator.
| Device ID | K072092 |
| 510k Number | K072092 |
| Device Name: | XPOD/XMAP NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | XAVANT TECHNOLOGY (PTY), LTD. 181 SOUTPANSBERG RD. RIETONDALE Pretoria, ZA 0084 |
| Contact | Roche Van Rensburg |
| Correspondent | Roche Van Rensburg XAVANT TECHNOLOGY (PTY), LTD. 181 SOUTPANSBERG RD. RIETONDALE Pretoria, ZA 0084 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-11-15 |
| Summary: | summary |