Masimo O3 Regional Oximeter System

Oximeter, Tissue Saturation

Masimo Corporation

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo O3 Regional Oximeter System.

Pre-market Notification Details

Device IDK214072
510k NumberK214072
Device Name:Masimo O3 Regional Oximeter System
ClassificationOximeter, Tissue Saturation
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactKertana Shankar
CorrespondentKertana Shankar
Masimo Corporation 52 Discovery Irvine,  CA  92618
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-05-06

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