FDA 510(k)

Reon

Número K: K250763 · 2025-05-12

RequerenteC.E.I.B.Med

Data da decisão2025-05-12

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reon is the device name listed in this FDA 510(k) record. The listed applicant is C.E.I.B.Med. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250763. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reon?

Reon is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is C.E.I.B.Med. The 510(k) number is K250763.

When did Reon receive FDA 510(k) clearance?

Reon received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250763.

Who is the listed applicant for Reon?

The FDA 510(k) record lists C.E.I.B.Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reon?

The FDA product code for Reon is EBF.

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Fonte oficial

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