K203113 is an FDA 510(k) clearance for the Masimo SedLine Sedation Monitor and Accessories. This device is classified as a Index-generating Electroencephalograph Software (Class II - Special Controls, product code OLW).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on February 25, 2022, 498 days after receiving the submission on October 15, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 882.1400. Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User..
| 510(k) Number | K203113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2020 |
| Decision Date | February 25, 2022 |
| Days to Decision | 498 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OLW — Index-generating Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User. |