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FDA 510(k)

Philips IntelliSite病理解决方案

K号: K192259 · 2019-09-20

决定日期2019-09-20
产品代码PSY
咨询委员会PA 请注意,由于您没有提供具体的医疗设备监管文本,我无法提供准确的翻译。如果您能提供具体的文本内容,我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Philips IntelliSite Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Philips Electronics Nederland B.V.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192259. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Philips IntelliSite Pathology Solution?

Philips IntelliSite Pathology Solution is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Philips Electronics Nederland B.V.. The 510(k) number is K192259.

When did Philips IntelliSite Pathology Solution receive FDA 510(k) clearance?

Philips IntelliSite Pathology Solution received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192259.

Who is the listed applicant for Philips IntelliSite Pathology Solution?

The FDA 510(k) record lists Philips Electronics Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliSite Pathology Solution?

The FDA product code for Philips IntelliSite Pathology Solution is PSY.

相关临床试验

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列明Philips Electronics Nederland B.V.为申报人的其他记录

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相关器械(代码:PSY)

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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