510(k) K063488

MAXO2 CU by Maxtec, Inc. — Product Code CCL

K063488 is an FDA 510(k) premarket notification submitted by Maxtec, Inc. for the device "MAXO2 CU". The FDA issued a decision of Substantially Equivalent on February 22, 2007. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Maxtec, Inc. has at least 9 other 510(k) clearances on record.