510(k) K953530

DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A by Biosound, Inc. — Product Code IYO

K953530 is an FDA 510(k) premarket notification submitted by Biosound, Inc. for the device "DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A". The FDA issued a decision of Substantially Equivalent on April 8, 1996. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Biosound, Inc. has at least 10 other 510(k) clearances on record.