510(k) K240601

SnapshotNIR model KD205 by Kent Imaging, Inc. — Product Code MUD

K240601 is an FDA 510(k) premarket notification submitted by Kent Imaging, Inc. for the device "SnapshotNIR model KD205". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Kent Imaging, Inc. has at least 4 other 510(k) clearances on record.