XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
Device Facts
| Record ID | K052112 |
|---|---|
| Device Name | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 |
| Applicant | Excel Tech. , Ltd. |
| Product Code | IKN · Physical Medicine |
| Decision Date | Oct 28, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
