510(k) K942700

DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 by Critikon Company, LLC — Product Code MHX

K942700 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340". The FDA issued a decision of Substantially Equivalent on March 1, 1995. 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.