Carescape SpO2 - Masimo

Oximeter

Masimo Corporation

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Carescape Spo2 - Masimo.

Pre-market Notification Details

Device IDK212876
510k NumberK212876
Device Name:Carescape SpO2 - Masimo
ClassificationOximeter
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactKertana Shankar
CorrespondentKertana Shankar
Masimo Corporation 52 Discovery Irvine,  CA  92618
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-09
Decision Date2021-10-08

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