HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

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 Clearsight Module, Acumen Hypotension Prediction Index.

Pre-market Notification Details

Device IDK203687
510k NumberK203687
Device Name:HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
ClassificationComputer, Diagnostic, Programmable
Applicant Edwards Lifesciences, LLC 1 Edwards Way Irvine,  CA  92614
ContactVarad Raghuwanshi
CorrespondentVarad Raghuwanshi
Edwards Lifesciences, LLC 1 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 Received2020-12-17
Decision Date2021-05-28

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