510(k) K911351

BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP by Biochem International, Inc. — Product Code DXN

K911351 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP". The FDA issued a decision of Substantially Equivalent on August 22, 1991. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Biochem International, Inc. has at least 10 other 510(k) clearances on record.