四重DR
K 號：K161937 · 2016-10-06
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器材摘要
CuattroDR is the device name listed in this FDA 510(k) record. The listed applicant is Cuattro, LLC. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K161937. 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 CuattroDR?
CuattroDR is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Cuattro, LLC. The 510(k) number is K161937.
When did CuattroDR receive FDA 510(k) clearance?
CuattroDR received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161937.
Who is the listed applicant for CuattroDR?
The FDA 510(k) record lists Cuattro, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CuattroDR?
The FDA product code for CuattroDR is KPR.
相關臨床試驗
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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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