510(k) K945947

NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER by Nellcor, Inc. — Product Code DXN

K945947 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Nellcor, Inc. has at least 10 other 510(k) clearances on record.