510(k) K912188

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 by Critikon Company, LLC — Product Code MHX

K912188 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Critikon Company, LLC has at least 10 other 510(k) clearances on record.