510(k) K200031

Neonatal Phototherapy System by Avalon Biomedical (Shenzhen) Limited — Product Code LBI

K200031 is an FDA 510(k) premarket notification submitted by Avalon Biomedical (Shenzhen) Limited for the device "Neonatal Phototherapy System". The FDA issued a decision of Substantially Equivalent on October 5, 2020. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700.