510(k) K885061

SIEMENS INTRAVAGINAL TRANSDUCER by Siemens Medical Solutions USA, Inc. — Product Code HEM

K885061 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS INTRAVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on February 23, 1989. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.