XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
Device Facts
| Record ID | K010087 |
|---|---|
| Device Name | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP |
| Applicant | Excel Tech. , Ltd. |
| Product Code | GWF · Neurology |
| Decision Date | Mar 19, 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.
