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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843997016056 K201770 000
00843997016049 K201770 000
00843997016032 K201770 000
00843997015530 K201770 000
00843997013284 K201770 000
00843997013123 K201770 000
00843997000666 K201770 000

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