510(k) K162687

Paragon 2 by Meridian Medical Systems, LLC — Product Code IZL

K162687 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, LLC for the device "Paragon 2". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Meridian Medical Systems, LLC has at least 7 other 510(k) clearances on record.