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FDA 510(k)

Quick-20m醫療設備規範文本翻譯: Quick-20m醫療設備規範文本: 注意事項:以下翻譯僅供參考,具體內容以官方文件為準。 Quick-20m醫療設備 FDA許可證號:[FDA許可證號] 510(k)許可證號:[510(k)許可證號] PMA許可證號:[PMA許可證號] NCT試驗編號:[NCT試驗編號] PMID編號:[PMID編號] 識別碼:[識別碼] 相關網址:[相關網址]

K 號:K203331 · 2021-05-20

申請人Cgx, LLC
決定日期2021-05-20
產品代碼GWL
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

Quick-20m is the device name listed in this FDA 510(k) record. The listed applicant is Cgx, LLC. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203331. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quick-20m?

Quick-20m is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Cgx, LLC. The 510(k) number is K203331.

When did Quick-20m receive FDA 510(k) clearance?

Quick-20m received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203331.

Who is the listed applicant for Quick-20m?

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

What is the FDA product code for Quick-20m?

The FDA product code for Quick-20m is GWL.

相關臨床試驗

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相關器械(代碼:GWL)

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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