XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
Device Facts
| Record ID | K010092 |
|---|---|
| Device Name | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) |
| Applicant | Excel Tech. , Ltd. |
| Product Code | GWF · Neurology |
| Decision Date | Apr 2, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
