VR101 適用於陰道內潤滑環
K 號：K203377 · 2021-05-20
廣告
決定日期2021-05-20
產品代碼QPD
諮詢委員會OB設備之醫療設備規範文本翻譯如下：
關於OB設備的醫療設備規範文件：
此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：
識別碼：[識別碼]
網址：[網址]
政策：醫療規範-v1
決定相當於
器材摘要
VR101 Lubricating Intravaginal Ring is the device name listed in this FDA 510(k) record. The listed applicant is J3 Bioscience, Inc.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203377. The device is classified under product code QPD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VR101 Lubricating Intravaginal Ring?
VR101 Lubricating Intravaginal Ring is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is J3 Bioscience, Inc.. The 510(k) number is K203377.
When did VR101 Lubricating Intravaginal Ring receive FDA 510(k) clearance?
VR101 Lubricating Intravaginal Ring received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203377.
Who is the listed applicant for VR101 Lubricating Intravaginal Ring?
The FDA 510(k) record lists J3 Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VR101 Lubricating Intravaginal Ring?
The FDA product code for VR101 Lubricating Intravaginal Ring is QPD.
相關臨床試驗
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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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