510(k) K112402

ULTRAMAXO2 OXYGEN ANALYER by Maxtec, LLC — Product Code CCL

K112402 is an FDA 510(k) premarket notification submitted by Maxtec, LLC for the device "ULTRAMAXO2 OXYGEN ANALYER". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Maxtec, LLC has at least 9 other 510(k) clearances on record.