510(k) K131528

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER by CIVCO Medical Instruments Co., Inc. — Product Code ITX

K131528 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "NON-PYROGENIC ULTRASOUND TRANSDUCER COVER". The FDA issued a decision of Substantially Equivalent on June 11, 2013. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.