510(k) K061730

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 by Osmetech, Inc. — Product Code CEM

K061730 is an FDA 510(k) premarket notification submitted by Osmetech, Inc. for the device "OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044". The FDA issued a decision of Substantially Equivalent on August 4, 2006. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Osmetech, Inc. has at least 3 other 510(k) clearances on record.