510(k) K022188

RADIANALYZER, MODEL 12710 by Radi Medical Systems AB — Product Code DQK

K022188 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "RADIANALYZER, MODEL 12710". The FDA issued a decision of Substantially Equivalent on October 3, 2002. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.