Masimo Rad-97 Pulse CO-Oximeter And Accessories, Masimo Radical-7 Pulse CO-Oximeter And Accessories, Masimo Radius-7 Pulse CO-Oximeter 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 Pulse Co-oximeter And Accessories, Masimo Radical-7 Pulse Co-oximeter And Accessories, Masimo Radius-7 Pulse Co-oximeter And Accessories.

Pre-market Notification Details

Device IDK193242
510k NumberK193242
Device Name:Masimo Rad-97 Pulse CO-Oximeter And Accessories, Masimo Radical-7 Pulse CO-Oximeter And Accessories, Masimo Radius-7 Pulse CO-Oximeter And Accessories
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactSindura Penubarthi
CorrespondentSindura Penubarthi
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)
Regulation Medical SpecialtyCardiovascular
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-02-27

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