RectalPro 75 給藥式直腸氣球
K 號：K180478 · 2018-11-13
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器材摘要
RectalPro 75 Endorectal Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Qlrad International , Ltd.. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K180478. The device is classified under product code PCT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RectalPro 75 Endorectal Balloon?
RectalPro 75 Endorectal Balloon is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Qlrad International , Ltd.. The 510(k) number is K180478.
When did RectalPro 75 Endorectal Balloon receive FDA 510(k) clearance?
RectalPro 75 Endorectal Balloon received FDA 510(k) clearance on 2018-11-13, under 510(k) number K180478.
Who is the listed applicant for RectalPro 75 Endorectal Balloon?
The FDA 510(k) record lists Qlrad International , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RectalPro 75 Endorectal Balloon?
The FDA product code for RectalPro 75 Endorectal Balloon is PCT.
相關臨床試驗
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相關器械（代碼：PCT）
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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