SedLine Sedation Monitor— 510(k) K172890

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K172890 for SedLine Sedation Monitor, Substantially Equivalent on 2018-01-26. Applicant: Masimo Corporation. Device class: 2.

Clearance details

Applicant: Masimo Corporation
Product code: Product code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2017-09-22
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLW

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K213273 — Brain Anesthesia Response Monitor (Bar Monitor)2023-09-01
K203113 — Masimo SedLine Sedation Monitor and Accessories2022-02-25

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