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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 a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2022-02-25 under approval 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. It is manufactured by Masimo Corporation. The 510(k) number is K203113.

When was Masimo SedLine Sedation Monitor and Accessories approved by the FDA?

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

What company makes Masimo SedLine Sedation Monitor and Accessories?

Masimo SedLine Sedation Monitor and Accessories is manufactured by Masimo Corporation.

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

NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring 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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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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