FERTI-LILY 孕育杯
K 號：K222969 · 2023-06-23
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決定日期2023-06-23
產品代碼HDR
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
FERTI-LILY Conception Cup is the device name listed in this FDA 510(k) record. The listed applicant is Rosesta Medical BV. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K222969. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FERTI-LILY Conception Cup?
FERTI-LILY Conception Cup is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Rosesta Medical BV. The 510(k) number is K222969.
When did FERTI-LILY Conception Cup receive FDA 510(k) clearance?
FERTI-LILY Conception Cup received FDA 510(k) clearance on 2023-06-23, under 510(k) number K222969.
Who is the listed applicant for FERTI-LILY Conception Cup?
The FDA 510(k) record lists Rosesta Medical BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FERTI-LILY Conception Cup?
The FDA product code for FERTI-LILY Conception Cup is HDR.
相關臨床試驗
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相關器械（代碼：HDR）
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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