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FDA 510(k)

Cuffix 注意:此翻譯僅根據給定的政策進行,並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。

K 號:K192611 · 2020-08-13

決定日期2020-08-13
產品代碼BSK
諮詢委員會AN
決定相當於

器材摘要

Cuffix is the device name listed in this FDA 510(k) record. The listed applicant is Biovo Technologies , Ltd.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K192611. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cuffix?

Cuffix is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Biovo Technologies , Ltd.. The 510(k) number is K192611.

When did Cuffix receive FDA 510(k) clearance?

Cuffix received FDA 510(k) clearance on 2020-08-13, under 510(k) number K192611.

Who is the listed applicant for Cuffix?

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

What is the FDA product code for Cuffix?

The FDA product code for Cuffix is BSK.

相關臨床試驗

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相關器械(代碼:BSK)

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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