The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xl Tek Evoked Potential Headbox, Model Ep-16.
| Device ID | K992313 |
| 510k Number | K992313 |
| Device Name: | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | John R Mumford |
| Correspondent | John R Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-09 |
| Decision Date | 1999-08-19 |