510(k) K915697

CRITIKON VITAL SIGNS MODULE by Critikon Company, LLC — Product Code DXN

K915697 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "CRITIKON VITAL SIGNS MODULE". The FDA issued a decision of Substantially Equivalent on July 1, 1993. 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.