FDA 510(k)

規範化醫療設備名稱：SPECCHIO

K 號：K260647 · 2026-04-02

決定日期2026-04-02

產品代碼PBX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SPECCHIO is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K260647. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPECCHIO?

SPECCHIO is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is El.En S.P.A.. The 510(k) number is K260647.

When did SPECCHIO receive FDA 510(k) clearance?

SPECCHIO received FDA 510(k) clearance on 2026-04-02, under 510(k) number K260647.

Who is the listed applicant for SPECCHIO?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECCHIO?

The FDA product code for SPECCHIO is PBX.

其他以 El.En S.P.A. 為申請人之記錄

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相關器械（代碼：PBX）

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官方來源

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