QLL

Left Ventricular Ejection Fraction Screening Tool

Product code: QLL
Device name: Left Ventricular Ejection Fraction Screening Tool
Device class: Class N
Medical specialty: Unknown
Marketing pathway: EUA - Emergency Use Authorization

FDA classification definition

Electrocardiogram Low Ejection Fraction Tool to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction (LVEF) for use as a diagnostic aid to screen for potential cardiac complications or underlying cardiac conditions, in adult patients. For use during declared public health emergency.

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

Official FDA classification page: QLL

Classification and pathway per current FDA publications. Data from openFDA (CC0).