貝雅應用器 (BAP-GB-01)
K 號：K242031 · 2025-04-02
廣告
決定日期2025-04-02
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
Béa Applicator (BAP-GB-01) is the device name listed in this FDA 510(k) record. The listed applicant is Stepone Fertility Ltd (T/A Béa Fertility). It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242031. 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 Béa Applicator (BAP-GB-01)?
Béa Applicator (BAP-GB-01) is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Stepone Fertility Ltd (T/A Béa Fertility). The 510(k) number is K242031.
When did Béa Applicator (BAP-GB-01) receive FDA 510(k) clearance?
Béa Applicator (BAP-GB-01) received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242031.
Who is the listed applicant for Béa Applicator (BAP-GB-01)?
The FDA 510(k) record lists Stepone Fertility Ltd (T/A Béa Fertility) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Béa Applicator (BAP-GB-01)?
The FDA product code for Béa Applicator (BAP-GB-01) is HDR.
相關臨床試驗
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。
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。
廣告