SKOUT軟體
K 號：K213686 · 2022-08-12
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器材摘要
SKOUT Software is the device name listed in this FDA 510(k) record. The listed applicant is Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K213686. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SKOUT Software?
SKOUT Software is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Iterative Scopes, Inc.. The 510(k) number is K213686.
When did SKOUT Software receive FDA 510(k) clearance?
SKOUT Software received FDA 510(k) clearance on 2022-08-12, under 510(k) number K213686.
Who is the listed applicant for SKOUT Software?
The FDA 510(k) record lists Iterative Scopes, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SKOUT Software?
The FDA product code for SKOUT Software is QNP.
相關臨床試驗
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其他以 Iterative Scopes, Inc. 為申請人之記錄
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。
相關器械（代碼：QNP）
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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