510(k) K081073

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F by Pausch, LLC — Product Code OWB

K081073 is an FDA 510(k) premarket notification submitted by Pausch, LLC for the device "HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Pausch, LLC has at least 8 other 510(k) clearances on record.