510(k) K992638

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 by Critikon Company, LLC — Product Code MWI

K992638 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400". The FDA issued a decision of Substantially Equivalent on February 24, 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. Critikon Company, LLC has at least 10 other 510(k) clearances on record.