路92醫療088存取系統
K 號：K201518 · 2020-08-14
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器材摘要
Route 92 Medical 088 Access System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K201518. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Route 92 Medical 088 Access System?
Route 92 Medical 088 Access System is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Route 92 Medical. The 510(k) number is K201518.
When did Route 92 Medical 088 Access System receive FDA 510(k) clearance?
Route 92 Medical 088 Access System received FDA 510(k) clearance on 2020-08-14, under 510(k) number K201518.
Who is the listed applicant for Route 92 Medical 088 Access System?
The FDA 510(k) record lists Route 92 Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Route 92 Medical 088 Access System?
The FDA product code for Route 92 Medical 088 Access System is QJP.
相關臨床試驗
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相關器械（代碼：QJP）
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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