Masimo SedLine Sedation Monitor and Accessories— 510(k) K203113

Name: FDA 510(k) clearance K203113
Creator: U.S. Food and Drug Administration
Published: 2022-02-25

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K203113 for Masimo SedLine Sedation Monitor and Accessories, Substantially Equivalent on 2022-02-25. 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: 2020-10-15
Decision date: 2022-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLW

view all

K260907 — BIS Advance pEEG Module2026-08-13
K260880 — SedLine Sedation Monitor2026-07-10
K230693 — BIS Advance Monitoring System2024-02-26
K213273 — Brain Anesthesia Response Monitor (Bar Monitor)2023-09-01
K202621 — NeuroSENSE Monitoring System, Model NS-9012021-08-05

More clearances from Masimo Corporation

view all

K253417 — Masimo Root Monitoring System2026-08-12
K254209 — Radius VSM and Accessories2026-06-04
K243324 — Masimo O3 Regional Oximeter2025-07-17
K250757 — Radius VSM and Accessories2025-05-29
K243305 — Masimo W12025-04-03

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