Clever One
K-Number: K250005 · 2025-05-23
ApplicantEwoosoft Co., Ltd.
Decision Date2025-05-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Clever One is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2025-05-23 under approval number K250005. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Clever One?
Clever One is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K250005.
When was Clever One approved by the FDA?
Clever One received FDA 510(k) clearance on 2025-05-23, under approval number K250005.
What company makes Clever One?
Clever One is manufactured by Ewoosoft Co., Ltd..
What is the FDA product code for Clever One?
The FDA product code for Clever One is QIH.
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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.