Masimo Rad-97 And Accessories

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 Rad-97 And Accessories.

Pre-market Notification Details

Device IDK170168
510k NumberK170168
Device Name:Masimo Rad-97 And Accessories
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant MASIMO CORPORATION 52 DISCOVERY Irvine,  CA  92618
ContactMarguerite Thomlinson
CorrespondentMarguerite Thomlinson
MASIMO CORPORATION 52 DISCOVERY Irvine,  CA  92618
Product CodeMWI  
Subsequent Product CodeBZQ
Subsequent Product CodeCCK
Subsequent Product CodeDPZ
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeJKS
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-19
Decision Date2017-09-14
Summary:summary

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