The following data is part of a premarket notification filed by Xltek with the FDA for Xltek Evoked Potential Headbox, Model Ep-8.
| Device ID | K002969 |
| 510k Number | K002969 |
| Device Name: | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | XLTEK 2568 BRISTOL CIRCLE Oakville, CA L6h 5s1 |
| Contact | Debbie Davy |
| Correspondent | Debbie Davy XLTEK 2568 BRISTOL CIRCLE Oakville, CA L6h 5s1 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-12-08 |