FDA 510(k)

DBSWIN 及 VistaEasy 匯影軟體

K 號：K161444 · 2016-06-21

決定日期2016-06-21

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

DBSWIN and VistaEasy Imaging Software is the device name listed in this FDA 510(k) record. The listed applicant is Duerr Dental AG. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K161444. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DBSWIN and VistaEasy Imaging Software?

DBSWIN and VistaEasy Imaging Software is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Duerr Dental AG. The 510(k) number is K161444.

When did DBSWIN and VistaEasy Imaging Software receive FDA 510(k) clearance?

DBSWIN and VistaEasy Imaging Software received FDA 510(k) clearance on 2016-06-21, under 510(k) number K161444.

Who is the listed applicant for DBSWIN and VistaEasy Imaging Software?

The FDA 510(k) record lists Duerr Dental AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DBSWIN and VistaEasy Imaging Software?

The FDA product code for DBSWIN and VistaEasy Imaging Software is LLZ.

其他以 Duerr Dental 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：LLZ）

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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