510(k) K853711

5.0 MHZ INTRACAVITARY SECTOR PROBE by General Electric Co. — Product Code HEM

K853711 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "5.0 MHZ INTRACAVITARY SECTOR PROBE". The FDA issued a decision of Substantially Equivalent on December 18, 1985. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. General Electric Co. has at least 10 other 510(k) clearances on record.