Cleared Traditional

Masimo Rad-G with Temperature

K213676 · Masimo Corporation · Anesthesiology
Apr 2023
Decision
510d
Days
Class 2
Risk

About This 510(k) Submission

K213676 is an FDA 510(k) clearance for the Masimo Rad-G with Temperature, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on April 16, 2023, 510 days after receiving the submission on November 22, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K213676 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2021
Decision Date April 16, 2023
Days to Decision 510 days
Submission Type Traditional
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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