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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 the device name listed in this FDA 510(k) record. The listed applicant is Belun Technology Company Limited. It received FDA 510(k) clearance on 2023-02-23 under 510(k) 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. The listed applicant is Belun Technology Company Limited. The 510(k) number is K222579.

When did Belun Sleep System BLS-100 receive FDA 510(k) clearance?

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

Who is the listed applicant for Belun Sleep System BLS-100?

The FDA 510(k) record lists Belun Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04121923Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep ApneaCOMPLETEDNCT04885062Belun Ring Platform With an Improved Algorithm for OSA AssessmentCOMPLETEDNCT07785999CES-EES Clinical Score and a Wearable Ring Sensor for Obstructive Sleep Apnea: Individual and Combined Validation Against In-Laboratory PolysomnographyRECRUITING

Other records listing Belun Technology Company Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234110Belun Ring BLR-200 (BLR-200)K211407Belun Ring BLR-100XK191417Belun RingK180174Belun Ring

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley MedicalK250882SANSA HSATHuxley Medical

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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