HEP · Class II · 21 CFR 884.2660

FDA Product Code HEP: Monitor, Blood-flow, Ultrasonic

Leading manufacturers include Edan Instruments, Inc., Imex Medical Systems, Inc. and Ultracell Medical Technologies, Inc..

4
Total
4
Cleared
142d
Avg days
1991
Since

FDA 510(k) Cleared Monitor, Blood-flow, Ultrasonic Devices (Product Code HEP)

4 devices
1–4 of 4
Cleared Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K101960
Edan Instruments, Inc.
Radiology · 29d
Cleared Sep 15, 1992
ULTRACELL INSTRUMENT WIPE
K920353
Ultracell Medical Technologies, Inc.
Obstetrics & Gynecology · 232d
Cleared Jun 24, 1991
POCKET DOP 3
K910462
Imex Medical Systems, Inc.
Radiology · 140d

About Product Code HEP - Regulatory Context