Product code
QLL: Left ventricular ejection fraction screening tool
FDA product code · Not Classified · Cardiovascular
Key facts
| Product code | QLL |
|---|---|
| Device | Left ventricular ejection fraction screening tool |
| Device class | Not Classified |
| Review panel | Cardiovascular |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database