MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

Oximeter

MASIMO CORP.

The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5v Pulse Oximeter, Model Rad-5v.

Pre-market Notification Details

Device IDK033296
510k NumberK033296
Device Name:MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
ClassificationOximeter
Applicant MASIMO CORP. 2852 KELVIN AVE. Irvine,  CA  92614 -5826
ContactJames J Cronin
CorrespondentJames J Cronin
MASIMO CORP. 2852 KELVIN AVE. Irvine,  CA  92614 -5826
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-14
Decision Date2004-02-19
Summary:summary

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