FDA 510(k)

Z5-BL

K 號：K200386 · 2020-10-14

決定日期2020-10-14

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Z5-BL is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2020-10-14 under 510(k) number K200386. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Z5-BL?

Z5-BL is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Z-Systems AG. The 510(k) number is K200386.

When did Z5-BL receive FDA 510(k) clearance?

Z5-BL received FDA 510(k) clearance on 2020-10-14, under 510(k) number K200386.

Who is the listed applicant for Z5-BL?

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

What is the FDA product code for Z5-BL?

The FDA product code for Z5-BL is DZE.

其他以 Z-Systems 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。

K201878ST-Z5 K201712Z5-TL K190243Z5-BL

相關器械（代碼：DZE）

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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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