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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 the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2022-05-06 under 510(k) 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. The listed applicant is Masimo Corporation. The 510(k) number is K214072.

When did Masimo O3 Regional Oximeter System receive FDA 510(k) clearance?

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

Who is the listed applicant for Masimo O3 Regional Oximeter System?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07223177Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric PopulationsRECRUITINGNCT05977686Hemoglobin Testing in Pregnant PatientsRECRUITINGNCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETED

Other records listing Masimo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253417Masimo Root Monitoring SystemK260880SedLine Sedation MonitorK254209Radius VSM and AccessoriesK243324Masimo O3 Regional OximeterK250757Radius VSM and AccessoriesK243305Masimo W1

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Related Devices (Code: MUD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent 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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