FDA 510(k)

診斷站 DS20

K 號：K152043 · 2016-05-06

決定日期2016-05-06

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

Diagnostic Station DS20 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152043. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diagnostic Station DS20?

Diagnostic Station DS20 is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Schiller AG. The 510(k) number is K152043.

When did Diagnostic Station DS20 receive FDA 510(k) clearance?

Diagnostic Station DS20 received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152043.

Who is the listed applicant for Diagnostic Station DS20?

FDA 510(k) 記錄將 Schiller AG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Diagnostic Station DS20?

The FDA product code for Diagnostic Station DS20 is DPS.

其他以 Schiller AG 為申請人之記錄

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。

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相關器械（代碼：DPS）

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。

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官方來源

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