BIOSLEEP
Device Facts
| Record ID | K002622 |
|---|---|
| Device Name | BIOSLEEP |
| Applicant | Oxford Biosignals Limited |
| Product Code | OLZ · Neurology |
| Decision Date | Oct 23, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.