Cleared Traditional

Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories

K193242 · Masimo Corporation · Anesthesiology

Feb 2020

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K193242 is an FDA 510(k) clearance for the Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories, 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 February 27, 2020, 94 days after receiving the submission on November 25, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K193242 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2019
Decision Date	February 27, 2020
Days to Decision	94 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