510(k) K002248

DINAMAP PRO 1000 MONITOR, MODEL 1000 by Critikon Company, LLC — Product Code DXN

K002248 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP PRO 1000 MONITOR, MODEL 1000". The FDA issued a decision of Substantially Equivalent on September 21, 2000. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Critikon Company, LLC has at least 10 other 510(k) clearances on record.