510(k) K211383

NFLK-2501 Portable X-ray Unit by Neuf, Inc. — Product Code IZL

K211383 is an FDA 510(k) premarket notification submitted by Neuf, Inc. for the device "NFLK-2501 Portable X-ray Unit". The FDA issued a decision of Substantially Equivalent on August 13, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Neuf, Inc. has at least 1 other 510(k) clearance on record.