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FDA 510(k)

德菲放大器

K 號:K243746 · 2025-03-12

決定日期2025-03-12
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

Delphi Amplifier is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neroscience. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K243746. 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 Delphi Amplifier?

Delphi Amplifier is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Quantalx Neroscience. The 510(k) number is K243746.

When did Delphi Amplifier receive FDA 510(k) clearance?

Delphi Amplifier received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243746.

Who is the listed applicant for Delphi Amplifier?

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

What is the FDA product code for Delphi Amplifier?

The FDA product code for Delphi Amplifier 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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