Devices · Fifth Eye Inc.

AHI System

Fifth Eye Inc. is listed for AHI System (K212219). The FDA list gives December 3, 2021 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) 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 “Substantially Equivalent.” 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/pmn.cfm?ID=K212219

Official FDA database record

Date of final decision

December 3, 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

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary