DeviceClearance

Product code QNV— Cardiovascular

AHI System

Classification name
Adjunctive Hemodynamic Indicator With Decision Point
Device class
Class 2
Regulation
21 CFR 870.2220
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QNV under 21 CFR 870.2220, via openFDA

Market context for product code QNV

FDA has cleared 3 devices under product code QNV between 2021 and 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNV

Recent clearances under product code QNV

Data sourced from openFDA. This site is unofficial and independent of the FDA.