FDA 510(k)

DEKA TORO

K号: K240752 · 2024-05-16

决定日期2024-05-16

产品代码GEX

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决定实质等同

器械摘要

DEKA TORO 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 2024-05-16 under 510(k) number K240752. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the DEKA TORO?

DEKA TORO is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is El.En S.P.A.. The 510(k) number is K240752.

When did DEKA TORO receive FDA 510(k) clearance?

DEKA TORO received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240752.

Who is the listed applicant for DEKA TORO?

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 DEKA TORO?

The FDA product code for DEKA TORO is GEX. This falls under the Gastroenterology category.

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。

K260647SPECCHIO K251432Olo K243683Deka Bluebeam K250281DEKA LOTUS K241459MOTUS PRO 家族 K233473DEKA LOTUS

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明El.En S.P.A.为申报人的其他记录

相关器械（代码：GEX）

官方来源