510(k) K874378

DINAMAP VITAL SIGNS MONITOR, MODEL 8100T by Critikon Company, LLC — Product Code DXN

K874378 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP VITAL SIGNS MONITOR, MODEL 8100T". The FDA issued a decision of Substantially Equivalent on December 30, 1987. 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.