MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
Device Facts
| Record ID | K881177 |
|---|---|
| Device Name | MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD |
| Applicant | Nihon Kohden America, Inc. |
| Product Code | GWL · Neurology |
| Decision Date | Sep 30, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1835 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
