FDA 510(k)

T-Cuff

K 號：K162365 · 2017-02-16

決定日期2017-02-16

產品代碼KCY

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

T-Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Terumobct, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162365. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T-Cuff?

T-Cuff is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Terumobct, Inc.. The 510(k) number is K162365.

When did T-Cuff receive FDA 510(k) clearance?

T-Cuff received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162365.

Who is the listed applicant for T-Cuff?

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

What is the FDA product code for T-Cuff?

The FDA product code for T-Cuff is KCY.

其他以 Terumobct, Inc. 為申請人之記錄

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相關器械（代碼：KCY）

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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