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FDA 510(k)

SedLine Sedation Monitor

K-Number: K172890 · 2018-01-26

ApplicantMasimo Corporation
Decision Date2018-01-26
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SedLine Sedation Monitor is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2018-01-26 under approval 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. It is manufactured by Masimo Corporation. The 510(k) number is K172890.

When was SedLine Sedation Monitor approved by the FDA?

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

What company makes SedLine Sedation Monitor?

SedLine Sedation Monitor is manufactured by Masimo Corporation.

What is the FDA product code for SedLine Sedation Monitor?

The FDA product code for SedLine Sedation Monitor is OLW.

Related Clinical Trials

NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07568093 PARO-agitation-study RECRUITING NCT06732050 Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement Endometriosis COMPLETED NCT07500779 Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy: A Brain Function Monitoring (SedLine)-Guided Randomized Controlled Trial (NAMSHIC) COMPLETED NCT07489157 Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy NOT_YET_RECRUITING

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Related Devices (Code: OLW)

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

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.

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