HEN — Caliper, Fetal Head, Ultrasonic Class II

FDA Device Classification

FDA product code HEN covers "Caliper, Fetal Head, Ultrasonic", a Class II medical device regulated under 21 CFR 884.2225. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HEN
Device Class
Class II
Regulation Number
884.2225
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No