510(k) K012035

BRAUN PRECISION SENSOR PRO, MODEL BP 2590 by Braun GmbH — Product Code DXN

K012035 is an FDA 510(k) premarket notification submitted by Braun GmbH for the device "BRAUN PRECISION SENSOR PRO, MODEL BP 2590". The FDA issued a decision of Substantially Equivalent on July 27, 2001. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Braun GmbH has at least 8 other 510(k) clearances on record.