510(k) K020956

VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA by Microtek Medical, Inc. — Product Code MUI

K020956 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA". The FDA issued a decision of Substantially Equivalent on May 16, 2002. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.