510(k) K112825

AVITA ARM TYPE BLOOD PRESSURE MONITOR by Avita Corporation — Product Code DXN

K112825 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AVITA ARM TYPE BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on January 18, 2012. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Avita Corporation has at least 10 other 510(k) clearances on record.