Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI Sensor, Masimo Rad-G Reusable Sensor

Oximeter

Masimo Corporation

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-g Pulse Oximeter, Masimo Rad-g Yi Sensor, Masimo Rad-g Reusable Sensor.

Pre-market Notification Details

Device IDK201770
510k NumberK201770
Device Name:Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI Sensor, Masimo Rad-G Reusable Sensor
ClassificationOximeter
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactKatelynn Kirby
CorrespondentKatelynn Kirby
Masimo Corporation 52 Discovery Irvine,  CA  92618
Product CodeDQA  
Subsequent Product CodeBZQ
Subsequent Product CodeDPZ
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-09-24

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