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 IDK201432
510k NumberK201432
Device Name:Masimo O3 Regional Oximeter System
ClassificationOximeter, Tissue Saturation
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactSindura Penubarthi
CorrespondentSindura Penubarthi
Masimo Corporation 52 Discovery Irvine,  CA  92618
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-08-29

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