Cleared Traditional

Masimo SedLine Sedation Monitor and Accessories

K203113 · Masimo Corporation · Anesthesiology

Feb 2022

Decision

498d

Days

Class 2

Risk

About This 510(k) Submission

K203113 is an FDA 510(k) clearance for the Masimo SedLine Sedation Monitor and Accessories, 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 review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K203113 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.