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FDA 510(k)

Masimo O3 Regional Oximeter System

K-Number: K162603 · 2017-05-26

ApplicantMasimo Corporation
Decision Date2017-05-26
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo O3 Regional Oximeter System is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2017-05-26 under approval number K162603. 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 System?

Masimo O3 Regional Oximeter System is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Masimo Corporation. The 510(k) number is K162603.

When was Masimo O3 Regional Oximeter System approved by the FDA?

Masimo O3 Regional Oximeter System received FDA 510(k) clearance on 2017-05-26, under approval number K162603.

What company makes Masimo O3 Regional Oximeter System?

Masimo O3 Regional Oximeter System is manufactured by Masimo Corporation.

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

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

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Related PubMed Literature

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Other Devices by Masimo Corporation

K162675Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter K160940Masimo Disposable Transflectance Forehead Sensor K153225Masimo Root Monitoring System and Accessories K160526Masimo O3 Regional Oximeter System K151644Masimo Root Vital Signs Monitoring System and Accessories K171121Masimo Root Monitoring System and Accessories

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Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K163070Kent CameraKent Imaging, Inc.

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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