FDA 510(k)

SedLine Sedation Monitor

K-Number: K172890 · 2018-01-26

Decision Date2018-01-26

Product CodeOLW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SedLine Sedation Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172890. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SedLine Sedation Monitor?

SedLine Sedation Monitor is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Masimo Corporation. The 510(k) number is K172890.

When did SedLine Sedation Monitor receive FDA 510(k) clearance?

SedLine Sedation Monitor received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172890.

Who is the listed applicant for SedLine Sedation Monitor?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SedLine Sedation Monitor?

The FDA product code for SedLine Sedation Monitor is OLW.

Related Clinical Trials

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Other records listing Masimo Corporation as applicant

K253417Masimo Root Monitoring System K260880SedLine Sedation Monitor K254209Radius VSM and Accessories K243324Masimo O3 Regional Oximeter K250757Radius VSM and Accessories K243305Masimo W1

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Related Devices (Code: OLW)

K260907BIS™ Advance pEEG ModuleCovidien LP K260880SedLine Sedation MonitorMasimo Corporation K230693BIS™ Advance Monitoring SystemCovidien, LLC K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.