FDA 510(k)

VistaCam iX 識別證

K 號：K150672 · 2016-01-27

決定日期2016-01-27

產品代碼NBL

諮詢委員會DE

決定相當於

器材摘要

VistaCam iX Proof is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental AG. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K150672. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VistaCam iX Proof?

VistaCam iX Proof is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Durr Dental AG. The 510(k) number is K150672.

When did VistaCam iX Proof receive FDA 510(k) clearance?

VistaCam iX Proof received FDA 510(k) clearance on 2016-01-27, under 510(k) number K150672.

Who is the listed applicant for VistaCam iX Proof?

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

What is the FDA product code for VistaCam iX Proof?

The FDA product code for VistaCam iX Proof is NBL.

其他以 Durr 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。

K143290DBSWIN 及 VistaEasy 匯影軟體

相關器械（代碼：NBL）

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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