510(k) K254129

Spectrum-2 by Neko Health AB — Product Code MUD

K254129 is an FDA 510(k) premarket notification submitted by Neko Health AB for the device "Spectrum-2". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Neko Health AB has at least 1 other 510(k) clearance on record.