FDA 510(k)

SPECCHIO

K号: K260647 · 2026-04-02

决定日期2026-04-02

产品代码PBX

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决定实质等同

器械摘要

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.

常见问题

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.

列明El.En S.P.A.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251432Olo K243683Deka Bluebeam K250281DEKA LOTUS K241459MOTUS PRO 家族 K240752DEKA TORO K233473DEKA LOTUS

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