510(k) K260880— SedLine Sedation Monitor

Substantially Equivalent

Masimo Corporation

Clearance details

Applicant: Masimo Corporation
Product code: Code OLW
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 ↗

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