Product code QNV

Device name: Adjunctive Hemodynamic Indicator With Decision Point
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.2220
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K221203	AHI System	Fifth Eye, Inc.	2022-07-14
K212219	AHI System	Fifth Eye, Inc.	2021-12-03
DEN200022	Analytic for Hemodynamic Instability (AHI)	Fifth Eye, Inc.	2021-03-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
B823AHIV200	AHI System	Fifth Eye, Inc.	2022-02-12
B823AHIP100	Analytic for Hemodynamic Instability	Fifth Eye, Inc.	2021-05-10

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