510(k) K925285

DUALTHERM(R) CARDIAC OUTPUT COMPUTER by B. Braun of America, Inc. — Product Code DQK

K925285 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "DUALTHERM(R) CARDIAC OUTPUT COMPUTER". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.