Analytic For Hemodynamic Instability (AHI)

Adjunctive Hemodynamic Indicator With Decision Point

Fifth Eye Inc.

The following data is part of a De Novo classification by Fifth Eye Inc. with the FDA for Analytic For Hemodynamic Instability (ahi).

Pre-market Notification Details

DeNovo IDDEN200022
Device Name:Analytic For Hemodynamic Instability (AHI)
ClassificationAdjunctive Hemodynamic Indicator With Decision Point
Applicant Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor,  MI  48104
ContactJennifer A Baird
Product CodeQNV  
CFR Regulation Number870.2220 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypeDirect
Date Received2020-04-03
Decision Date2021-03-01
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B823AHIP100 DEN200022 000

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