510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QLLNot classified

Left Ventricular Ejection Fraction Screening Tool

Unknown
FDA source (opens on fda.gov)

QLL is the FDA product code for Left Ventricular Ejection Fraction Screening Tool. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QLL
Device name
Left Ventricular Ejection Fraction Screening Tool
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QLL.