BIS ENGINE
Device Facts
| Record ID | K002837 |
|---|---|
| Device Name | BIS ENGINE |
| Applicant | Aspect Medical Systems, Inc. |
| Product Code | OLW · Neurology |
| Decision Date | Sep 19, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
