FDA 510(k)

Reon

K 號：K250763 · 2025-05-12

申請人C.E.I.B.Med

決定日期2025-05-12

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：EBF）

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官方來源

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