510(k) K810953

MODEL 533 PHOTOTHERAPY UNIT by Narco Air-Shields — Product Code LBI

K810953 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "MODEL 533 PHOTOTHERAPY UNIT". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Narco Air-Shields has at least 10 other 510(k) clearances on record.