510(k) K060820

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 by Suntech Medical, Inc. — Product Code DXN

K060820 is an FDA 510(k) premarket notification submitted by Suntech Medical, Inc. for the device "CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060". The FDA issued a decision of Substantially Equivalent on June 7, 2006. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Suntech Medical, Inc. has at least 7 other 510(k) clearances on record.