510(k) K860233

5 MHZ INTRACAVITARY PROBE, MODEL H4222V by General Electric Co. — Product Code HEM

K860233 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "5 MHZ INTRACAVITARY PROBE, MODEL H4222V". The FDA issued a decision of Substantially Equivalent on June 2, 1986. 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.