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FDA 510(k)

德菲刺激器

K 號：K242345 · 2024-11-05

申請人Quantalx Neuroscience
決定日期2024-11-05
產品代碼GWF
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 Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242345. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Delphi Stimulator?

Delphi Stimulator is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Quantalx Neuroscience. The 510(k) number is K242345.

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

Delphi Stimulator received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242345.

Who is the listed applicant for Delphi Stimulator?

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

What is the FDA product code for Delphi Stimulator?

The FDA product code for Delphi Stimulator is GWF.

相關臨床試驗

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相關器械（代碼：GWF）

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。

K263010ISIS頭箱，ISIS神經刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3：神經資訊系統Alphatec Spine, Inc.K243982尼可萊特EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK234092SafeOp 3：神經資訊系統Alphatec Spine, Inc.

官方來源

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