Devices · Fifth Eye Inc.

Analytic for Hemodynamic Instability (AHI)

Fifth Eye Inc. is listed for Analytic for Hemodynamic Instability (AHI) (DEN200022). The FDA list gives March 1, 2021 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QNV as “Adjunctive Hemodynamic Indicator With Decision Point”: An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200022

Official FDA database record

Date of final decision

March 1, 2021

Company on the FDA list

Fifth Eye Inc.

Lead panel

Cardiovascular

Primary product code

QNV

openFDA device name for the code

Adjunctive Hemodynamic Indicator With Decision Point

Device class

2

Regulation number

870.2220

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned