510(k) K051040

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR by Medtronic Perfusion Systems — Product Code JOX

K051040 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR". The FDA issued a decision of Substantially Equivalent on May 24, 2005. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.