Masimo CARESCAPE SpO2 – Masimo With SpHb

Oximeter

Masimo Corporation

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

Pre-market Notification Details

Device IDK221953
510k NumberK221953
Device Name:Masimo CARESCAPE SpO2 – Masimo With SpHb
ClassificationOximeter
Applicant Masimo Corporation 52 Discovery Irvine,  CA  92618
ContactUnji Lee
CorrespondentUnji Lee
Masimo Corporation 52 Discovery Irvine,  CA  92618
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-08-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843997010818 K221953 000

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