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HEP — Monitor, Blood-Flow, Ultrasonic Class II

FDA Device Classification

Classification Details

Product Code
HEP
Device Class
Class II
Regulation Number
884.2660
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101960edan instrumentsSONOTRAX SERIES ULTRASONIC POCKET DOPPLERAugust 10, 2010
K023082bionet companyBABYCAREMarch 3, 2003
K920353ultracell medical technologiesULTRACELL INSTRUMENT WIPESeptember 15, 1992
K910462imex medical systemsPOCKET DOP 3June 24, 1991