Cleared Traditional

Masimo Centroid System

K191882 · Masimo Corporation · Anesthesiology

Apr 2020

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K191882 is an FDA 510(k) clearance for the Masimo Centroid System, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on April 22, 2020, 282 days after receiving the submission on July 15, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K191882 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2019
Decision Date	April 22, 2020
Days to Decision	282 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300