Cleared Special

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

K232389 · Masimo Corporation · Anesthesiology
Sep 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K232389 is an FDA 510(k) clearance for the Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on September 7, 2023, 29 days after receiving the submission on August 9, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K232389 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2023
Decision Date September 07, 2023
Days to Decision 29 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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