K062549 is an FDA 510(k) clearance for the XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on October 4, 2006, 35 days after receiving the submission on August 30, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K062549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2006 |
| Decision Date | October 04, 2006 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |