MK6 ERA SYSTEM
Device Facts
| Record ID | K810473 |
|---|---|
| Device Name | MK6 ERA SYSTEM |
| Applicant | Amplaid USA, Inc. |
| Product Code | GWJ · Neurology |
| Decision Date | Apr 29, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
