生物流軟體II
K 號：K201040 · 2020-07-29
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器材摘要
Bioflux Software II is the device name listed in this FDA 510(k) record. The listed applicant is Biotricity. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K201040. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bioflux Software II?
Bioflux Software II is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Biotricity. The 510(k) number is K201040.
When did Bioflux Software II receive FDA 510(k) clearance?
Bioflux Software II received FDA 510(k) clearance on 2020-07-29, under 510(k) number K201040.
Who is the listed applicant for Bioflux Software II?
The FDA 510(k) record lists Biotricity as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bioflux Software II?
The FDA product code for Bioflux Software II is DSH.
相關臨床試驗
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其他以 Biotricity 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：DSH）
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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