510(k) K821159

IN-LINE OXYGEN MONITORING SYSTEM by G.D. Searle and Co. — Product Code DRY

K821159 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "IN-LINE OXYGEN MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 1982. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.