FDA 510(k) Applications for Medical Device Product Code "HEP"
(Monitor, Blood-Flow, Ultrasonic)

FDA 510(k) Number Applicant Device Name Decision Date
K023082 BIONET COMPANY LTD BABYCARE 03/03/2003
K101960 EDAN INSTRUMENTS, INC. SONOTRAX SERIES ULTRASONIC POCKET DOPPLER 08/10/2010


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