MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

Oximeter

MASIMO CORP.

The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables.

Pre-market Notification Details

Device IDK031330
510k NumberK031330
Device Name:MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-28
Decision Date2003-05-12
Summary:summary

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