510(k) K101960

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER by Edan Instruments, Inc. — Product Code HEP

K101960 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "SONOTRAX SERIES ULTRASONIC POCKET DOPPLER". The FDA issued a decision of Substantially Equivalent on August 10, 2010. The device falls under product code HEP (Monitor, Blood-Flow, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.