510(k) K910381

BIOCHEM TEMPERATURE/ FIO2 MODULE by Biochem International, Inc. — Product Code CCL

K910381 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "BIOCHEM TEMPERATURE/ FIO2 MODULE". The FDA issued a decision of Substantially Equivalent on August 22, 1991. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Biochem International, Inc. has at least 10 other 510(k) clearances on record.