頭電療治療儀用於治療抑鬱症
PMA 核准號：P230024 · 2026-07-14
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決定日期2026-07-14
PMA 編號P230024
產品代碼JXK
器械分類3 類
醫療專科N
法規編號21 CFR 8
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
器材摘要
Cranial electrotherapy stimulator to treat depression is the device name listed in this FDA 510(k) record. The listed applicant is Flow Neuroscience AB. It received FDA 510(k) clearance on 2026-07-14. The device is classified under product code JXK. It was reviewed by the NE advisory panel.
常見問題
What is the Cranial electrotherapy stimulator to treat depression?
Cranial electrotherapy stimulator to treat depression is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Flow Neuroscience AB.
When did Cranial electrotherapy stimulator to treat depression receive FDA 510(k) clearance?
The clearance date for Cranial electrotherapy stimulator to treat depression can be found in the official FDA records.
Who is the listed applicant for Cranial electrotherapy stimulator to treat depression?
The FDA 510(k) record lists Flow Neuroscience AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cranial electrotherapy stimulator to treat depression?
The FDA product code for Cranial electrotherapy stimulator to treat depression is JXK.
相關臨床試驗
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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