FDA 510(k), K222579, Belun Sleep System BLS-100
FDA 510(k), K222579, Belun Sleep System BLS-100
| 510(k) Number | K222579 |
| Device Classification Name | Ventilatory Effort Recorder |
| Device Name | Belun Sleep System BLS-100 |
| Applicant | Belun Technology Company Limited Unit 218, 2/F, Core Bldg. 2, # 1 Science Park West Ave., Hong Kong Science Park Sha Tin, CN |
| Regulation Number | 868.2375 |
| Classification Product Code | MNR |
| Date Received | 08/25/2022 |
| Decision Date | 02/23/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Anesthesiology |
| 510k Review Panel | Anesthesiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 9860 |
| Redacted Pages | 9034 |
| Unredacted Pages | 826 |
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