神經耳-安娜™
K 號：K243709 · 2025-08-25
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器材摘要
NeuroEars-Anna™ is the device name listed in this FDA 510(k) record. The listed applicant is Neuroears, Inc.. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K243709. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NeuroEars-Anna™?
NeuroEars-Anna™ is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Neuroears, Inc.. The 510(k) number is K243709.
When did NeuroEars-Anna™ receive FDA 510(k) clearance?
NeuroEars-Anna™ received FDA 510(k) clearance on 2025-08-25, under 510(k) number K243709.
Who is the listed applicant for NeuroEars-Anna™?
The FDA 510(k) record lists Neuroears, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeuroEars-Anna™?
The FDA product code for NeuroEars-Anna™ is GWN.
相關臨床試驗
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相關器械（代碼：GWN）
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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