510(k) K133989

AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM by Mortara Instrument, Inc. — Product Code DXN

K133989 is an FDA 510(k) premarket notification submitted by Mortara Instrument, Inc. for the device "AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2014. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Mortara Instrument, Inc. has at least 10 other 510(k) clearances on record.