510(k) K850298

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM by Cabot Medical Corp. — Product Code FEO

K850298 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.