510(k) K811391

OXIMETRIX ACCU SAT CPB by Oximetrix, Inc. — Product Code DRY

K811391 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "OXIMETRIX ACCU SAT CPB". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Oximetrix, Inc. has at least 10 other 510(k) clearances on record.