MASIMO SET RAD 57 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 Rad 57 Pulse Co-oximeter.

Pre-market Notification Details

Device IDK042536
510k NumberK042536
Device Name:MASIMO SET RAD 57 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  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-20
Decision Date2005-01-19
Summary:summary

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