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FDA 510(k) Application Details - K183646
Device Classification Name
More FDA Info for this Device
510(K) Number
K183646
Device Name
Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure
Applicant
Edwards Lifeciences, LLC
One Edwards Way
Irvine, CA 92614 US
Other 510(k) Applications for this Company
Contact
Lisa Gilman
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QAQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2018
Decision Date
05/21/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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