510(k) K002030

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES by Invivo Research, Inc. — Product Code MWI

K002030 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES". The FDA issued a decision of Substantially Equivalent on September 26, 2000. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Invivo Research, Inc. has at least 10 other 510(k) clearances on record.