FDA 510(k)

AR_N型植入系統

K 號：K171297 · 2018-01-31

決定日期2018-01-31

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

AR_N Type Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotem Co., Ltd.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K171297. 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 AR_N Type Implant System?

AR_N Type Implant System is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Biotem Co., Ltd.. The 510(k) number is K171297.

When did AR_N Type Implant System receive FDA 510(k) clearance?

AR_N Type Implant System received FDA 510(k) clearance on 2018-01-31, under 510(k) number K171297.

Who is the listed applicant for AR_N Type Implant System?

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

What is the FDA product code for AR_N Type Implant System?

The FDA product code for AR_N Type Implant System is DZE.

其他以 Biotem Co., Ltd. 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。

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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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