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FDA 510(k)

Belun Ring BLR-100X

K-Number: K211407 · 2021-10-21

ApplicantBelun Technology Company Limited
Decision Date2021-10-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Belun Ring BLR-100X 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 2021-10-21 under 510(k) number K211407. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Belun Ring BLR-100X?

Belun Ring BLR-100X is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Belun Technology Company Limited. The 510(k) number is K211407.

When did Belun Ring BLR-100X receive FDA 510(k) clearance?

Belun Ring BLR-100X received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211407.

Who is the listed applicant for Belun Ring BLR-100X?

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 Ring BLR-100X?

The FDA product code for Belun Ring BLR-100X is DQA.

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 AssessmentCOMPLETED

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)K222579Belun Sleep System BLS-100K191417Belun RingK180174Belun Ring

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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

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