LXE — Doppler, Fetal, Ultrasound Class II

FDA Device Classification

FDA product code LXE covers "Doppler, Fetal, Ultrasound", a Class II medical device regulated under 21 CFR 884.2660. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
LXE
Device Class
Class II
Regulation Number
884.2660
Submission Type
Review Panel
RA
Medical Specialty
Obstetrics/Gynecology
Implant
No