The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Neuropath, Model Pk1070.
| Device ID | K053058 |
| 510k Number | K053058 |
| Device Name: | XLTEK NEUROPATH, MODEL PK1070 |
| Classification | Device, Nerve Conduction Velocity Measurement |
| 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 | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-31 |
| Decision Date | 2006-02-07 |