AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
Device Facts
| Record ID | K861014 |
|---|---|
| Device Name | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) |
| Applicant | Amplaid USA, Inc. |
| Product Code | GWL · Neurology |
| Decision Date | Aug 20, 1986 |
| 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).
