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FDA 510(k)

高V+

K 號:K161114 · 2017-04-12

申請人Teknimed Sas
決定日期2017-04-12
產品代碼NDN
諮詢委員會或
決定相當於

器材摘要

HIGH V+ is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed Sas. It received FDA 510(k) clearance on 2017-04-12 under 510(k) number K161114. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HIGH V+?

HIGH V+ is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Teknimed Sas. The 510(k) number is K161114.

When did HIGH V+ receive FDA 510(k) clearance?

HIGH V+ received FDA 510(k) clearance on 2017-04-12, under 510(k) number K161114.

Who is the listed applicant for HIGH V+?

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

What is the FDA product code for HIGH V+?

The FDA product code for HIGH V+ is NDN.

其他以 Teknimed Sas 為申請人之記錄

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相關器械(代碼:NDN)

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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