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FDA 510(k)

貝甘克 4T Plus

K 號:K233010 · 2023-11-21

申請人Belega, Inc.
決定日期2023-11-21
產品代碼NFO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Beagank 4T Plus is the device name listed in this FDA 510(k) record. The listed applicant is Belega, Inc.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K233010. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Beagank 4T Plus?

Beagank 4T Plus is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Belega, Inc.. The 510(k) number is K233010.

When did Beagank 4T Plus receive FDA 510(k) clearance?

Beagank 4T Plus received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233010.

Who is the listed applicant for Beagank 4T Plus?

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

What is the FDA product code for Beagank 4T Plus?

The FDA product code for Beagank 4T Plus is NFO.

相關臨床試驗

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相關器械(代碼:NFO)

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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