510(k) K112408

POLY-CHEM 90 ISE MODULE by Polymedco, Inc. — Product Code CEM

K112408 is an FDA 510(k) premarket notification submitted by Polymedco, Inc. for the device "POLY-CHEM 90 ISE MODULE". The FDA issued a decision of Substantially Equivalent on November 4, 2011. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Polymedco, Inc. has at least 10 other 510(k) clearances on record.