510(k) K151525

Amia Automated PD System with Sharesource by Deka Research and Development — Product Code FKX

K151525 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "Amia Automated PD System with Sharesource". The FDA issued a decision of Substantially Equivalent on October 9, 2015. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Deka Research and Development has at least 10 other 510(k) clearances on record.