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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name adjunctive hemodynamic indicator with decision point
De Novo Number DEN200022
Device Name Analytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.
110 miller avenue, suite 300
ann arbor,  MI  48104
Contact jennifer a baird
Regulation Number870.2220
Classification Product Code
Date Received04/03/2020
Decision Date 03/01/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct