Bright High Flow
K-Number: K200155 · 2020-11-30
ApplicantGenoss Co., Ltd.
Decision Date2020-11-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bright High Flow is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2020-11-30 under approval number K200155. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bright High Flow?
Bright High Flow is a medical device that received FDA 510(k) clearance on 2020-11-30. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K200155.
When was Bright High Flow approved by the FDA?
Bright High Flow received FDA 510(k) clearance on 2020-11-30, under approval number K200155.
What company makes Bright High Flow?
Bright High Flow is manufactured by Genoss Co., Ltd..
What is the FDA product code for Bright High Flow?
The FDA product code for Bright High Flow is EBF.
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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.