HEK · Class II · 21 CFR 884.2660

FDA Product Code HEK: Monitor, Heart Sound, Fetal, Ultrasonic

Leading manufacturers include Terumo America, Inc..

5
Total
5
Cleared
105d
Avg days
1977
Since

FDA 510(k) Cleared Monitor, Heart Sound, Fetal, Ultrasonic Devices (Product Code HEK)

5 devices
1–5 of 5
Cleared Jul 14, 1977
DOPPLER (UTD-5 & UTD-6)
K771211
Terumo America, Inc.
Obstetrics & Gynecology · 9d

About Product Code HEK - Regulatory Context