Cleared Traditional

SedLine Sedation Monitor

K172890 · Masimo Corporation · Neurology

Jan 2018

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K172890 is an FDA 510(k) clearance for the SedLine Sedation Monitor, 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 January 26, 2018, 126 days after receiving the submission on September 22, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K172890 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2017
Decision Date	January 26, 2018
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Neurology (NE)
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.