510(k) K051992

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM by Vidacare Corporation — Product Code FMI

K051992 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 2005. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Vidacare Corporation has at least 10 other 510(k) clearances on record.