The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 And 105238.
| Device ID | K062549 |
| 510k Number | K062549 |
| Device Name: | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
| Classification | Stimulator, Nerve |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2006-10-04 |