Reon
K-Number: K250763 · 2025-05-12
ApplicantC.E.I.B.Med
Decision Date2025-05-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Reon is a medical device manufactured by C.E.I.B.Med. It received FDA 510(k) clearance on 2025-05-12 under approval number K250763. 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 Reon?
Reon is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by C.E.I.B.Med. The 510(k) number is K250763.
When was Reon approved by the FDA?
Reon received FDA 510(k) clearance on 2025-05-12, under approval number K250763.
What company makes Reon?
Reon is manufactured by C.E.I.B.Med.
What is the FDA product code for Reon?
The FDA product code for Reon 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.