MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR

Oximeter

MASIMO CORP.

The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Lnop-tf-i Resuable Transflectance Sensor.

Pre-market Notification Details

Device IDK032551
510k NumberK032551
Device Name:MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
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 Received2003-08-19
Decision Date2004-02-19
Summary:summary

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