Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Masimo O3 Regional Oximeter System

K-Number: K214072 · 2022-05-06

ApplicantMasimo Corporation
Decision Date2022-05-06
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 2022-05-06 under approval number K214072. 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 2022-05-06. It is manufactured by Masimo Corporation. The 510(k) number is K214072.

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

Masimo O3 Regional Oximeter System received FDA 510(k) clearance on 2022-05-06, under approval number K214072.

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.

Related Clinical Trials

NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT07568431 Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery NOT_YET_RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02560506 Development of Low Cost Devices to Increase Access to Treadmill Training COMPLETED NCT05851326 Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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

View all 41 devices →

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. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation

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.

↑