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FDA 510(k)

Forwarts 注意:此翻譯僅根據您提供的指示進行,並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL。

K 號:K201366 · 2021-01-21

決定日期2021-01-21
產品代碼GEH
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

Forwarts is the device name listed in this FDA 510(k) record. The listed applicant is Pronova Laboratories BV. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K201366. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Forwarts?

Forwarts is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Pronova Laboratories BV. The 510(k) number is K201366.

When did Forwarts receive FDA 510(k) clearance?

Forwarts received FDA 510(k) clearance on 2021-01-21, under 510(k) number K201366.

Who is the listed applicant for Forwarts?

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

What is the FDA product code for Forwarts?

The FDA product code for Forwarts is GEH.

相關臨床試驗

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相關器械(代碼:GEH)

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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