HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

Computer, Diagnostic, Programmable

Edwards Lfesciences

The following data is part of a premarket notification filed by Edwards Lfesciences with the FDA for Hemosphere Advanced Monitor, Viewfinder Remote, Hemosphere Advanced Monitoring Platform.

Pre-market Notification Details

Device IDK211465
510k NumberK211465
Device Name:HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
ClassificationComputer, Diagnostic, Programmable
Applicant Edwards Lfesciences One Edwards Way Irvine,  CA  92614
ContactChirag Shah
CorrespondentChirag Shah
Edwards Lfesciences 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 Received2021-05-11
Decision Date2021-07-08

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