Cleared Special

Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor

K201770 · Masimo Corporation · Anesthesiology
Sep 2020
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K201770 is an FDA 510(k) clearance for the Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on September 24, 2020, 87 days after receiving the submission on June 29, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K201770 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2020
Decision Date September 24, 2020
Days to Decision 87 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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