FDA 510(k)

MDPC-8127

K 號：K203364 · 2021-04-15

決定日期2021-04-15

產品代碼PSY

諮詢委員會PA

決定相當於

器材摘要

MDPC-8127 is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K203364. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MDPC-8127?

MDPC-8127 is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Barco N.V.. The 510(k) number is K203364.

When did MDPC-8127 receive FDA 510(k) clearance?

MDPC-8127 received FDA 510(k) clearance on 2021-04-15, under 510(k) number K203364.

Who is the listed applicant for MDPC-8127?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDPC-8127?

The FDA product code for MDPC-8127 is PSY.

其他以 Barco N.V. 為申請人之記錄

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相關器械（代碼：PSY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253554Aperio GT 450 DX；Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD 檔片掃描系統Hamamatsu Photonics K.K.K251952病毒視野Virasoft Corporation K253606NanoZoomer S20MD 薄片掃描系統；NanoZoomer S360MD 薄片掃描系統Hamamatsu Photonics K.K.K243871飛利浦 IntelliSite 病理解決方案 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx 電子病理學解決方案Shandon Diagnostics Limited

官方來源

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