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FDA 510(k)

診斷影像彩色液晶顯示器

K 號:K161057 · 2016-05-13

決定日期2016-05-13
產品代碼PGY
諮詢委員會RA
決定相當於

器材摘要

Diagnostic Imaging Color LCD Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nec Display Solutions , Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K161057. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diagnostic Imaging Color LCD Monitor?

Diagnostic Imaging Color LCD Monitor is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Nec Display Solutions , Ltd.. The 510(k) number is K161057.

When did Diagnostic Imaging Color LCD Monitor receive FDA 510(k) clearance?

Diagnostic Imaging Color LCD Monitor received FDA 510(k) clearance on 2016-05-13, under 510(k) number K161057.

Who is the listed applicant for Diagnostic Imaging Color LCD Monitor?

The FDA 510(k) record lists Nec Display Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diagnostic Imaging Color LCD Monitor?

The FDA product code for Diagnostic Imaging Color LCD Monitor is PGY.

相關臨床試驗

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相關器械(代碼:PGY)

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。

官方來源

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