510(k) K800822

CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE by Kli — Product Code FAP

K800822 is an FDA 510(k) premarket notification submitted by Kli for the device "CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Kli has at least 10 other 510(k) clearances on record.