FDA 510(k)

Zircos-Com

K 號：K190139 · 2020-04-24

決定日期2020-04-24

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Zircos-Com is the device name listed in this FDA 510(k) record. The listed applicant is Bioden Co., Ltd.. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K190139. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zircos-Com?

Zircos-Com is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Bioden Co., Ltd.. The 510(k) number is K190139.

When did Zircos-Com receive FDA 510(k) clearance?

Zircos-Com received FDA 510(k) clearance on 2020-04-24, under 510(k) number K190139.

Who is the listed applicant for Zircos-Com?

The FDA 510(k) record lists Bioden Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zircos-Com?

The FDA product code for Zircos-Com is EBF.

其他以 Bioden Co., Ltd. 為申請人之記錄

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K201492非无菌氧化鋁塊

相關器械（代碼：EBF）

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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