Cleared Traditional

Masimo Stork

K223721 · Masimo Corporation · Anesthesiology
Dec 2023
Decision
368d
Days
Class 2
Risk

About This 510(k) Submission

K223721 is an FDA 510(k) clearance for the Masimo Stork, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 15, 2023, 368 days after receiving the submission on December 12, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K223721 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2022
Decision Date December 15, 2023
Days to Decision 368 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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