QLL — Left Ventricular Ejection Fraction Screening Tool Class N
FDA product code QLL covers "Left Ventricular Ejection Fraction Screening Tool", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QLL
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- 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.