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FDA 510(k)

Any-Etch

K号: K260485 · 2026-05-14

决定日期2026-05-14
产品代码KLE
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决定实质等同

器械摘要

Any-Etch is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260485. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Any-Etch?

Any-Etch is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K260485.

When did Any-Etch receive FDA 510(k) clearance?

Any-Etch received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260485.

Who is the listed applicant for Any-Etch?

FDA 510(k)记录将Mediclus Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Any-Etch?

The FDA product code for Any-Etch is KLE.

列明Mediclus Co., Ltd.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:KLE)

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。

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。

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