FDA 510(k)

微INR系统

K号: K243543 · 2025-02-27

决定日期2025-02-27

产品代码GJS

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

microINR System is the device name listed in this FDA 510(k) record. The listed applicant is Iline Microsystems, S.L.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K243543. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the microINR System?

microINR System is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Iline Microsystems, S.L.. The 510(k) number is K243543.

When did microINR System receive FDA 510(k) clearance?

microINR System received FDA 510(k) clearance on 2025-02-27, under 510(k) number K243543.

Who is the listed applicant for microINR System?

The FDA 510(k) record lists Iline Microsystems, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for microINR System?

The FDA product code for microINR System is GJS.

列明Iline Microsystems, S.L.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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官方来源

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