HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

Computer, Diagnostic, Programmable

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Hemosphere Advanced Monitor, Hemosphere Tissue Oximetry Module.

Pre-market Notification Details

Device IDK190205
510k NumberK190205
Device Name:HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
ClassificationComputer, Diagnostic, Programmable
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
ContactChirag Shah
CorrespondentChirag Shah
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
Product CodeDQK  
Subsequent Product CodeDQE
Subsequent Product CodeMUD
Subsequent Product CodeQAQ
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-04
Decision Date2019-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103200355 K190205 000

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