FDA 510(k)

RC-SwiftPrep

K 號：K250279 · 2025-07-02

決定日期2025-07-02

產品代碼KJJ

決定相當於

器材摘要

RC-SwiftPrep is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250279. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the RC-SwiftPrep?

RC-SwiftPrep is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K250279.

When did RC-SwiftPrep receive FDA 510(k) clearance?

RC-SwiftPrep received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250279.

Who is the listed applicant for RC-SwiftPrep?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RC-SwiftPrep?

The FDA product code for RC-SwiftPrep is KJJ.

其他以 Belport Company, Inc., Gingi-Pak 為申請人之記錄

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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相關器械（代碼：KJJ）

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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