HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Computer, Diagnostic, Programmable

Edwards Lifesiences, LLC

The following data is part of a premarket notification filed by Edwards Lifesiences, Llc with the FDA for Hemosphere Advanced Monitoring Platform, Hemosphere Clearsight Module.

Pre-market Notification Details

Device IDK201446
510k NumberK201446
Device Name:HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
ClassificationComputer, Diagnostic, Programmable
Applicant Edwards Lifesiences, LLC One Edwards Way Irvine,  CA  92614
ContactVarad Raghuwanshi
CorrespondentVarad Raghuwanshi
Edwards Lifesiences, LLC One Edwards Way Irvine,  CA  92614
Product CodeDQK  
Subsequent Product CodeDQE
Subsequent Product CodeDSB
Subsequent Product CodeDXN
Subsequent Product CodeMUD
Subsequent Product CodeQAQ
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-10-01

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