510(k) K211407

Belun Ring BLR-100X by Belun Technology Company Limited — Product Code DQA

K211407 is an FDA 510(k) premarket notification submitted by Belun Technology Company Limited for the device "Belun Ring BLR-100X". The FDA issued a decision of Substantially Equivalent on October 21, 2021. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Belun Technology Company Limited has at least 4 other 510(k) clearances on record.