The following data is part of a premarket notification filed by Xavant Technology (pty), Ltd. with the FDA for Stimtrode Single Use Nerve Stimulator.
| Device ID | K110118 |
| 510k Number | K110118 |
| Device Name: | STIMTRODE SINGLE USE NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | XAVANT TECHNOLOGY (PTY), LTD. 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Contact | Brian Rothman |
| Correspondent | Brian Rothman XAVANT TECHNOLOGY (PTY), LTD. 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-02-17 |
| Summary: | summary |