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 a medical device manufactured by Belun Technology Company Limited. It received FDA 510(k) clearance on 2021-10-21 under approval 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. It is manufactured by Belun Technology Company Limited. The 510(k) number is K211407.
When was Belun Ring BLR-100X approved by the FDA?
Belun Ring BLR-100X received FDA 510(k) clearance on 2021-10-21, under approval number K211407.
What company makes Belun Ring BLR-100X?
Belun Ring BLR-100X is manufactured by Belun Technology Company Limited.
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
Other Devices by Belun Technology Company Limited
Related Devices (Code: DQA)
K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation
K160231Model X-100C CO-Met Oximetry SystemNonin Medical, Inc.
K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation
K153021Fingertip Pulse Oximeter A310Amemo, Inc.
K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd.
K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.
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.