510(k) K232316

DEKA Infusion System, DEKA Administration Set by Deka Research and Development — Product Code LDR

K232316 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "DEKA Infusion System, DEKA Administration Set". The FDA issued a decision of Substantially Equivalent on March 1, 2024. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Deka Research and Development has at least 10 other 510(k) clearances on record.