Pixyl.Neuro 医療設備規範文本 Pixyl.Neuro 適用於醫療設備規範，已通過FDA認證，符合510(k)規定，並獲得PMA許可。該產品參與的臨床試驗代號為NCT，並在PubMed上登錄，編號為PMID。相關識別碼和網址如下： 識別碼：[識別碼] 網址：[網址]
K 號：K213253 · 2023-06-30
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器材摘要
Pixyl.Neuro is the device name listed in this FDA 510(k) record. The listed applicant is Pixyl SA. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K213253. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pixyl.Neuro?
Pixyl.Neuro is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Pixyl SA. The 510(k) number is K213253.
When did Pixyl.Neuro receive FDA 510(k) clearance?
Pixyl.Neuro received FDA 510(k) clearance on 2023-06-30, under 510(k) number K213253.
Who is the listed applicant for Pixyl.Neuro?
The FDA 510(k) record lists Pixyl SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pixyl.Neuro?
The FDA product code for Pixyl.Neuro is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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