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K 號：K221563 · 2022-10-24
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器材摘要
Neurosteer EEG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Neurosteer, Inc.. It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K221563. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Neurosteer EEG Recorder?
Neurosteer EEG Recorder is a medical device that received FDA 510(k) clearance on 2022-10-24. The listed applicant is Neurosteer, Inc.. The 510(k) number is K221563.
When did Neurosteer EEG Recorder receive FDA 510(k) clearance?
Neurosteer EEG Recorder received FDA 510(k) clearance on 2022-10-24, under 510(k) number K221563.
Who is the listed applicant for Neurosteer EEG Recorder?
The FDA 510(k) record lists Neurosteer, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Neurosteer EEG Recorder?
The FDA product code for Neurosteer EEG Recorder is OMC.
相關臨床試驗
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相關器械（代碼：OMC）
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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