FDA 510(k)

K3Pro Konus 新式基座與植體

K 號：K190192 · 2020-02-10

申請人Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

決定日期2020-02-10

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

K3Pro Konus New Abutments and Implants is the device name listed in this FDA 510(k) record. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K190192. 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 K3Pro Konus New Abutments and Implants?

K3Pro Konus New Abutments and Implants is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K190192.

When did K3Pro Konus New Abutments and Implants receive FDA 510(k) clearance?

K3Pro Konus New Abutments and Implants received FDA 510(k) clearance on 2020-02-10, under 510(k) number K190192.

Who is the listed applicant for K3Pro Konus New Abutments and Implants?

The FDA 510(k) record lists Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K3Pro Konus New Abutments and Implants?

The FDA product code for K3Pro Konus New Abutments and Implants is DZE.

其他以 Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG 為申請人之記錄

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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。

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官方來源

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