Cleared Traditional

Masimo O3 Regional Oximeter System

K201432 · Masimo Corporation · General & Plastic Surgery
Aug 2020
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K201432 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter System, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on August 29, 2020, 89 days after receiving the submission on June 1, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K201432 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2020
Decision Date August 29, 2020
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700