510(k) K002029

ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION by Zoll Medical Corp — Product Code DXN

K002029 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION". The FDA issued a decision of Substantially Equivalent on September 21, 2000. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Zoll Medical Corp has at least 10 other 510(k) clearances on record.