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FDA 510(k)

蘇2ura 近似設備

K 號:K201744 · 2021-06-17

決定日期2021-06-17
產品代碼OCW
諮詢委員會GU
決定相當於

器材摘要

Su2ura Approximation Device is the device name listed in this FDA 510(k) record. The listed applicant is Anchora Medical, Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K201744. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Su2ura Approximation Device?

Su2ura Approximation Device is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Anchora Medical, Ltd.. The 510(k) number is K201744.

When did Su2ura Approximation Device receive FDA 510(k) clearance?

Su2ura Approximation Device received FDA 510(k) clearance on 2021-06-17, under 510(k) number K201744.

Who is the listed applicant for Su2ura Approximation Device?

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

What is the FDA product code for Su2ura Approximation Device?

The FDA product code for Su2ura Approximation Device is OCW.

相關臨床試驗

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相關器械(代碼:OCW)

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。

官方來源

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