FDA 510(k)

OneRF 三叉神經開放式頻率探針

K 號：K251243 · 2025-08-15

決定日期2025-08-15

產品代碼GXI

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

OneRF Trigeminal Nerve Radiofrequency Probes is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251243. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OneRF Trigeminal Nerve Radiofrequency Probes?

OneRF Trigeminal Nerve Radiofrequency Probes is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K251243.

When did OneRF Trigeminal Nerve Radiofrequency Probes receive FDA 510(k) clearance?

OneRF Trigeminal Nerve Radiofrequency Probes received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251243.

Who is the listed applicant for OneRF Trigeminal Nerve Radiofrequency Probes?

The FDA 510(k) record lists Neuroone Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneRF Trigeminal Nerve Radiofrequency Probes?

The FDA product code for OneRF Trigeminal Nerve Radiofrequency Probes is GXI.

其他以 Neuroone Medical Technologies Corp. 為申請人之記錄

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相關器械（代碼：GXI）

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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