510(k) K022004

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 by Biosensors International-USA — Product Code DQO

K022004 is an FDA 510(k) premarket notification submitted by Biosensors International-USA for the device "CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1". The FDA issued a decision of Substantially Equivalent on March 12, 2003. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Biosensors International-USA has at least 1 other 510(k) clearance on record.