Prodigio 染色粉末
K 號：K171167 · 2017-12-13
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器材摘要
Prodigio Stain Powder is the device name listed in this FDA 510(k) record. The listed applicant is Operart, LLC. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K171167. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Prodigio Stain Powder?
Prodigio Stain Powder is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Operart, LLC. The 510(k) number is K171167.
When did Prodigio Stain Powder receive FDA 510(k) clearance?
Prodigio Stain Powder received FDA 510(k) clearance on 2017-12-13, under 510(k) number K171167.
Who is the listed applicant for Prodigio Stain Powder?
The FDA 510(k) record lists Operart, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Prodigio Stain Powder?
The FDA product code for Prodigio Stain Powder is EIH.
相關臨床試驗
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相關器械（代碼：EIH）
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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