510(k) K051368

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM by Schiller AG — Product Code DXN

K051368 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 9, 2005. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Schiller AG has at least 10 other 510(k) clearances on record.