510(k) K131919

ZOLL EPCR IOS by ZOLL Medical Corporation — Product Code DXJ

K131919 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL EPCR IOS". The FDA issued a decision of Substantially Equivalent on December 17, 2013. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.