SedLine Sedation Monitor
Device Facts
| Record ID | K260880 |
|---|---|
| Device Name | SedLine Sedation Monitor |
| Applicant | Masimo Corporation |
| Product Code | OLW · Neurology |
| Decision Date | Jul 10, 2026 |
| 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.
