510(k) K023338

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 by Fms, Finapres Medical Systems BV — Product Code DXN

K023338 is an FDA 510(k) premarket notification submitted by Fms, Finapres Medical Systems BV for the device "PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2". The FDA issued a decision of Substantially Equivalent on May 9, 2003. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Fms, Finapres Medical Systems BV has at least 1 other 510(k) clearance on record.