基本、主導柔軟
K 號:K170329 · 2017-03-24
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器材摘要
Basic, Dominant Flex is the device name listed in this FDA 510(k) record. The listed applicant is Modela AG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170329. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Basic, Dominant Flex?
Basic, Dominant Flex is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Modela AG. The 510(k) number is K170329.
When did Basic, Dominant Flex receive FDA 510(k) clearance?
Basic, Dominant Flex received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170329.
Who is the listed applicant for Basic, Dominant Flex?
The FDA 510(k) record lists Modela AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Basic, Dominant Flex?
The FDA product code for Basic, Dominant Flex is QPB.
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相關器械(代碼:QPB)
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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