FDA 510(k), K222579, Belun Sleep System BLS-100

510(K) Number: K222579
Device Name: Belun Sleep System BLS-100
Manufacturer: Belun Technology Company Limited
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 08/25/2022
Decision Date: 02/23/2023
Regulation Medical Specialty: Anesthesiology