510(k) K884578

POLARIX 2 AND POLARIX 2E by Dyna-Med — Product Code JAA

K884578 is an FDA 510(k) premarket notification submitted by Dyna-Med for the device "POLARIX 2 AND POLARIX 2E". The FDA issued a decision of Substantially Equivalent on February 9, 1989. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Dyna-Med has at least 3 other 510(k) clearances on record.