MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rainbow Set Rad 87 Pulse Co-oximeter And Accessories.

Pre-market Notification Details

Device IDK073024
510k NumberK073024
Device Name:MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
ClassificationOximeter
Applicant MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
ContactMarguerite Thomlinson
CorrespondentMarguerite Thomlinson
MASIMO CORPORATION 40 PARKER Irvine,  CA  92618
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-26
Decision Date2008-02-08
Summary:summary

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