FDA 510(k)

Adena-Zina System

K 號：K212066 · 2021-08-16

決定日期2021-08-16

產品代碼NKB

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決定相當於

器材摘要

Adena-Zina System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K212066. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Adena-Zina System?

Adena-Zina System is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K212066.

When did Adena-Zina System receive FDA 510(k) clearance?

Adena-Zina System received FDA 510(k) clearance on 2021-08-16, under 510(k) number K212066.

Who is the listed applicant for Adena-Zina System?

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

What is the FDA product code for Adena-Zina System?

The FDA product code for Adena-Zina System is NKB.

其他以 Shanghai Sanyou Medical 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：NKB）

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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