510(k) K871609

ULTRASOUND TRANSDUCER SHEATHS, STERILE by Amedic USA — Product Code ITX

K871609 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "ULTRASOUND TRANSDUCER SHEATHS, STERILE". The FDA issued a decision of Substantially Equivalent on July 15, 1987. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Amedic USA has at least 9 other 510(k) clearances on record.