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FDA 510(k)

hygh-tec 排水設備

K 號:K221400 · 2023-02-09

決定日期2023-02-09
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

hygh-tec drainage is the device name listed in this FDA 510(k) record. The listed applicant is Creative Balloons GmbH. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221400. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the hygh-tec drainage?

hygh-tec drainage is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Creative Balloons GmbH. The 510(k) number is K221400.

When did hygh-tec drainage receive FDA 510(k) clearance?

hygh-tec drainage received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221400.

Who is the listed applicant for hygh-tec drainage?

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

What is the FDA product code for hygh-tec drainage?

The FDA product code for hygh-tec drainage is KNT.

相關臨床試驗

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相關器械(代碼:KNT)

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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