SedLine Sedation Monitor— 510(k) K260880

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K260880 for SedLine Sedation Monitor, Substantially Equivalent on 2026-07-10. Applicant: Masimo Corporation. Device class: 2.

Clearance details

Applicant: Masimo Corporation
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2026-03-17
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.