510(k) K222579

Belun Sleep System BLS-100 by Belun Technology Company Limited — Product Code MNR

K222579 is an FDA 510(k) premarket notification submitted by Belun Technology Company Limited for the device "Belun Sleep System BLS-100". The FDA issued a decision of Substantially Equivalent on February 23, 2023. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Belun Technology Company Limited has at least 4 other 510(k) clearances on record.