Cleared Special

Carescape SpO2 - Masimo

K212876 · Masimo Corporation · Cardiovascular
Oct 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K212876 is an FDA 510(k) clearance for the Carescape SpO2 - Masimo, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 8, 2021, 29 days after receiving the submission on September 9, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K212876 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2021
Decision Date October 08, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
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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