510(k) K130236

RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 by Radiometer Medical Aps — Product Code JJS

K130236 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3". The FDA issued a decision of Substantially Equivalent on March 15, 2013. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.