ExamVue 雙用設備
K 號：K213057 · 2022-02-18
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器材摘要
ExamVue Duo is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213057. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ExamVue Duo?
ExamVue Duo is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K213057.
When did ExamVue Duo receive FDA 510(k) clearance?
ExamVue Duo received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213057.
Who is the listed applicant for ExamVue Duo?
The FDA 510(k) record lists Jpi Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExamVue Duo?
The FDA product code for ExamVue Duo is KPR.
相關臨床試驗
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其他以 Jpi Healthcare Co, Ltd. 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：KPR）
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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