P-範圍
K 號：K241502 · 2024-07-24
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器材摘要
P-SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Oui Medical, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241502. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the P-SCOPE?
P-SCOPE is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Oui Medical, Inc.. The 510(k) number is K241502.
When did P-SCOPE receive FDA 510(k) clearance?
P-SCOPE received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241502.
Who is the listed applicant for P-SCOPE?
The FDA 510(k) record lists Oui Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for P-SCOPE?
The FDA product code for P-SCOPE is GCJ.
相關臨床試驗
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相關器械（代碼：GCJ）
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
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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