Masimo Root Monitoring System And Accesories

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Monitoring System And Accesories.

Pre-market Notification Details

Device IDK142394
510k NumberK142394
Device Name:Masimo Root Monitoring System And Accesories
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
ContactMarguerite Thomlinson
CorrespondentMarguerite Thomlinson
MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-27
Decision Date2014-11-25
Summary:summary

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