FDA 510(k)

AllNEB

K号: K242354 · 2025-04-29

决定日期2025-04-29

产品代码CAF

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决定实质等同

器械摘要

AllNEB is the device name listed in this FDA 510(k) record. The listed applicant is Enchant Tek Co. , Ltd.. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K242354. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AllNEB?

AllNEB is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Enchant Tek Co. , Ltd.. The 510(k) number is K242354.

When did AllNEB receive FDA 510(k) clearance?

AllNEB received FDA 510(k) clearance on 2025-04-29, under 510(k) number K242354.

Who is the listed applicant for AllNEB?

The FDA 510(k) record lists Enchant Tek Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllNEB?

The FDA product code for AllNEB is CAF.

列明Enchant Tek 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。

K233855AllPEP

相关器械（代码：CAF）

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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官方来源

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