HEI — Monitor, Heart-Valve Movement, Fetal, Ultrasonic Class II

FDA Device Classification

FDA product code HEI covers "Monitor, Heart-Valve Movement, Fetal, Ultrasonic", a Class II medical device regulated under 21 CFR 884.2660. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 3 recent 510(k) clearances have been granted under this product code.