MASIMO SET RADICAL 7 PULSE CO-OXIMETER

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Set Radical 7 Pulse Co-oximeter.

Pre-market Notification Details

Device IDK061204
510k NumberK061204
Device Name:MASIMO SET RADICAL 7 PULSE CO-OXIMETER
ClassificationOximeter
Applicant MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
ContactJames J Cronin
CorrespondentJames J Cronin
MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
Product CodeDQA  
Subsequent Product CodeDPZ
Subsequent Product CodeJKS
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-01
Decision Date2006-07-27
Summary:summary

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