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FDA 510(k)

Masimo O3 Regional Oximeter

K-Number: K243324 · 2025-07-17

ApplicantMasimo Corporation
Decision Date2025-07-17
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo O3 Regional Oximeter is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2025-07-17 under approval number K243324. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo O3 Regional Oximeter?

Masimo O3 Regional Oximeter is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Masimo Corporation. The 510(k) number is K243324.

When was Masimo O3 Regional Oximeter approved by the FDA?

Masimo O3 Regional Oximeter received FDA 510(k) clearance on 2025-07-17, under approval number K243324.

What company makes Masimo O3 Regional Oximeter?

Masimo O3 Regional Oximeter is manufactured by Masimo Corporation.

What is the FDA product code for Masimo O3 Regional Oximeter?

The FDA product code for Masimo O3 Regional Oximeter is MUD.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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