K052112 is an FDA 510(k) clearance for the XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on October 28, 2005, 85 days after receiving the submission on August 4, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K052112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2005 |
| Decision Date | October 28, 2005 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | IKN — Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |