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FDA 510(k)

Belun Sleep System BLS-100

K-Number: K222579 · 2023-02-23

ApplicantBelun Technology Company Limited
Decision Date2023-02-23
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Belun Sleep System BLS-100 is a medical device manufactured by Belun Technology Company Limited. It received FDA 510(k) clearance on 2023-02-23 under approval number K222579. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Belun Sleep System BLS-100?

Belun Sleep System BLS-100 is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Belun Technology Company Limited. The 510(k) number is K222579.

When was Belun Sleep System BLS-100 approved by the FDA?

Belun Sleep System BLS-100 received FDA 510(k) clearance on 2023-02-23, under approval number K222579.

What company makes Belun Sleep System BLS-100?

Belun Sleep System BLS-100 is manufactured by Belun Technology Company Limited.

What is the FDA product code for Belun Sleep System BLS-100?

The FDA product code for Belun Sleep System BLS-100 is MNR.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT00743561 Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA) COMPLETED NCT07574918 Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis NOT_YET_RECRUITING

Other Devices by Belun Technology Company Limited

K180174Belun Ring K191417Belun Ring K211407Belun Ring BLR-100X K234110Belun Ring BLR-200 (BLR-200)

Related Devices (Code: MNR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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