510(k) K853599

LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI by Litton Datamedix — Product Code DXN

K853599 is an FDA 510(k) premarket notification submitted by Litton Datamedix for the device "LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI". The FDA issued a decision of Substantially Equivalent on March 21, 1986. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Litton Datamedix has at least 4 other 510(k) clearances on record.