FDA 510(k)

Erbe ESU 型号 VIO® 3n 及附件

K号: K251108 · 2025-08-29

决定日期2025-08-29

产品代码GEI

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决定实质等同

器械摘要

Erbe ESU Model VIO® 3n with Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251108. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Erbe ESU Model VIO® 3n with Accessories?

Erbe ESU Model VIO® 3n with Accessories is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K251108.

When did Erbe ESU Model VIO® 3n with Accessories receive FDA 510(k) clearance?

Erbe ESU Model VIO® 3n with Accessories received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251108.

Who is the listed applicant for Erbe ESU Model VIO® 3n with Accessories?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erbe ESU Model VIO® 3n with Accessories?

The FDA product code for Erbe ESU Model VIO® 3n with Accessories is GEI.

列明Erbe Elektromedizin GmbH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。

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相关器械（代码：GEI）

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。

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