FDA 510(k)

フィリップスインテリサイト病理ソリューション

K番号: K192259 · 2019-09-20

決定日2019-09-20

製品コードPSY

諮問委員会PA （注：原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてPhilips Electronics Nederland B.V.を記載するその他の記録

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