Adjunctive Hemodynamic Indicator With Decision Point For Military Use

FDA product code SAR · 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. The device is intended for use by the Military.

1510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K233249Appraise-HriSAR · Traditional The Surgeon General, Department of the Army…04/05/2024SE