510(k) K182770

Adult Intraosseous Infusion Device by Einstein Works, LLC — Product Code FMI

K182770 is an FDA 510(k) premarket notification submitted by Einstein Works, LLC for the device "Adult Intraosseous Infusion Device". The FDA issued a decision of Substantially Equivalent on Apr 9, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Einstein Works, LLC has 2 other 510(k) clearances on record.