K053058 is an FDA 510(k) clearance for the XLTEK NEUROPATH, MODEL PK1070. This device is classified as a Device, Nerve Conduction Velocity Measurement (Class II - Special Controls, product code JXE).
Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on February 7, 2006, 99 days after receiving the submission on October 31, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1550.
| 510(k) Number | K053058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2005 |
| Decision Date | February 07, 2006 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | JXE — Device, Nerve Conduction Velocity Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1550 |