HEK · Class II · 21 CFR 884.2660

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

Leading manufacturers include Summit Doppler Systems, Inc., Icare Newlife Technologies, Inc. and 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 Mar 20, 2015
Fetal Doppler
K142769
Icare Newlife Technologies, Inc.
Obstetrics & Gynecology · 176d
Cleared Apr 10, 2006
ECHOHEART TRANSVAGINAL DOPPLER PROBE
K060410
Summit Doppler Systems, Inc.
Radiology · 53d
Cleared Oct 22, 1990
FETAL PULSE DETECTOR MODEL DOP-1
K902190
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 159d
Cleared Dec 15, 1988
BIODOP(TM)
K883334
Diagnosis Related Systems, Inc.
Obstetrics & Gynecology · 128d
Cleared Jul 14, 1977
DOPPLER (UTD-5 & UTD-6)
K771211
Terumo America, Inc.
Obstetrics & Gynecology · 9d

About Product Code HEK - Regulatory Context