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FDA 510(k)

Masimo SedLine Sedation Monitor and Accessories

K-Number: K203113 · 2022-02-25

ApplicantMasimo Corporation
Decision Date2022-02-25
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Masimo SedLine Sedation Monitor and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K203113. 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 Masimo SedLine Sedation Monitor and Accessories?

Masimo SedLine Sedation Monitor and Accessories is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Masimo Corporation. The 510(k) number is K203113.

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

Masimo SedLine Sedation Monitor and Accessories received FDA 510(k) clearance on 2022-02-25, under 510(k) number K203113.

Who is the listed applicant for Masimo SedLine Sedation Monitor and Accessories?

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 Masimo SedLine Sedation Monitor and Accessories?

The FDA product code for Masimo SedLine Sedation Monitor and Accessories is OLW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06232876Continuous Versus Intermittent Ward MonitoringRECRUITINGNCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT06922461Clinical Performance of Masimo INVSENSOR00048 (DALI0001)TERMINATED

Other records listing Masimo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253417Masimo Root Monitoring SystemK260880SedLine Sedation MonitorK254209Radius VSM and AccessoriesK243324Masimo O3 Regional OximeterK250757Radius VSM and AccessoriesK243305Masimo W1

View all 42 devices →

Related Devices (Code: OLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.K172890SedLine Sedation MonitorMasimo Corporation

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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