SAR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2220

Medical specialty

Cardiovascular

FDA 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. The device is intended for use by the Military.

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