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FDA 510(k)

JLK-ICH

K号: K243363 · 2025-01-03

申请人JLK, Inc.
决定日期2025-01-03
产品代码QAS
咨询委员会RA
决定实质等同

器械摘要

JLK-ICH is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K243363. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the JLK-ICH?

JLK-ICH is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is JLK, Inc.. The 510(k) number is K243363.

When did JLK-ICH receive FDA 510(k) clearance?

JLK-ICH received FDA 510(k) clearance on 2025-01-03, under 510(k) number K243363.

Who is the listed applicant for JLK-ICH?

The FDA 510(k) record lists JLK, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JLK-ICH?

The FDA product code for JLK-ICH is QAS.

列明JLK, Inc.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:QAS)

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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