MODIFICATION TO LNCS OXIMETRY SENSORS

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Modification To Lncs Oximetry Sensors.

Pre-market Notification Details

Device IDK051212
510k NumberK051212
Device Name:MODIFICATION TO LNCS OXIMETRY SENSORS
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-11
Decision Date2005-07-12
Summary:summary

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