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 IDK183697
510k NumberK183697
Device Name:Masimo Rad-97 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  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-31
Decision Date2019-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843997014687 K183697 000
00843997002950 K183697 000
00843997003032 K183697 000
00843997016797 K183697 000
00843997014694 K183697 000
00843997014700 K183697 000
00843997014779 K183697 000
00843997014786 K183697 000
00843997014830 K183697 000
00843997014663 K183697 000
00843997017442 K183697 000

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