FDA 510(k)

UNiD IB3D ALIF

K 號：K200316 · 2020-10-30

決定日期2020-10-30

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

UNiD IB3D ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K200316. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UNiD IB3D ALIF?

UNiD IB3D ALIF is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Medicrea International SA. The 510(k) number is K200316.

When did UNiD IB3D ALIF receive FDA 510(k) clearance?

UNiD IB3D ALIF received FDA 510(k) clearance on 2020-10-30, under 510(k) number K200316.

Who is the listed applicant for UNiD IB3D ALIF?

The FDA 510(k) record lists Medicrea International SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNiD IB3D ALIF?

The FDA product code for UNiD IB3D ALIF is MAX.

其他以 Medicrea International SA 為申請人之記錄

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相關器械（代碼：MAX）

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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