The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Protektor Stimulator, Models 10247 & 10248.
| Device ID | K040358 |
| 510k Number | K040358 |
| Device Name: | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE RD. Oakville, Ontario, CA L6h 5s1 |
| Contact | Cameron Mahon |
| Correspondent | Cameron Mahon EXCEL TECH. LTD. 2568 BRISTOL CIRCLE RD. Oakville, Ontario, CA L6h 5s1 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-08-06 |