乳房景 v1.0
K 號：K211431 · 2021-08-02
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器材摘要
breastscape v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K211431. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the breastscape v1.0?
breastscape v1.0 is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Olea Medical. The 510(k) number is K211431.
When did breastscape v1.0 receive FDA 510(k) clearance?
breastscape v1.0 received FDA 510(k) clearance on 2021-08-02, under 510(k) number K211431.
Who is the listed applicant for breastscape v1.0?
The FDA 510(k) record lists Olea Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for breastscape v1.0?
The FDA product code for breastscape v1.0 is QIH.
相關臨床試驗
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其他以 Olea Medical 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：QIH）
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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