Left Ventricular Ejection Fraction Screening Tool

QLL · Not classified · Unknown

Classification

FDA Product Code: QLL
Device class: Not classified
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 8
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown