Adjunctive Hemodynamic Indicator With Decision Point

FDA product code QNV · Class II (moderate risk) · 21 CFR 870.2220 · Cardiovascular

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K221203AHI SystemQNV · Special Fifth Eye, Inc.07/14/2022SE
K212219AHI SystemQNV · Traditional Fifth Eye, Inc.12/03/2021SE