LNOP BLUE OXIMETRY SENSOR

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Lnop Blue Oximetry Sensor.

Pre-market Notification Details

Device IDK051439
510k NumberK051439
Device Name:LNOP BLUE OXIMETRY SENSOR
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 Received2005-06-02
Decision Date2005-07-15
Summary:summary

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