510(k) K083382

CHROMA, MODEL: RZ153C by Scottcare Corporation — Product Code MWJ

K083382 is an FDA 510(k) premarket notification submitted by Scottcare Corporation for the device "CHROMA, MODEL: RZ153C". The FDA issued a decision of Substantially Equivalent on August 13, 2009. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Scottcare Corporation has at least 4 other 510(k) clearances on record.