AHI System

Adjunctive Hemodynamic Indicator With Decision Point

Fifth Eye Inc.

The following data is part of a premarket notification filed by Fifth Eye Inc. with the FDA for Ahi System.

Pre-market Notification Details

Device IDK221203
510k NumberK221203
Device Name:AHI System
ClassificationAdjunctive Hemodynamic Indicator With Decision Point
Applicant Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor,  MI  48104
ContactJennifer Baird
CorrespondentDonna-Bea Tillman
Biologics Consulting 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeQNV  
CFR Regulation Number870.2220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-26
Decision Date2022-07-14

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