QNV

Adjunctive Hemodynamic Indicator With Decision Point

Product code

QNV

Device name

Adjunctive Hemodynamic Indicator With Decision Point

Device class

Class 2

21 CFR

21 CFR 870.2220

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).