FDA 510(k)

希望&她陰道擴張器

K 號：K222492 · 2023-06-27

決定日期2023-06-27

產品代碼HDX

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

Hope&Her Vaginal Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Lujena, Inc.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K222492. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hope&Her Vaginal Dilators?

Hope&Her Vaginal Dilators is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Lujena, Inc.. The 510(k) number is K222492.

When did Hope&Her Vaginal Dilators receive FDA 510(k) clearance?

Hope&Her Vaginal Dilators received FDA 510(k) clearance on 2023-06-27, under 510(k) number K222492.

Who is the listed applicant for Hope&Her Vaginal Dilators?

The FDA 510(k) record lists Lujena, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hope&Her Vaginal Dilators?

The FDA product code for Hope&Her Vaginal Dilators is HDX.

其他以 Lujena, Inc. 為申請人之記錄

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K233689希望&她陰道擴張器

相關器械（代碼：HDX）

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。

K241748親密玫瑰陰道擴張器Plus EV Holdings Dba Intimate Rose K233689希望&她陰道擴張器Lujena, Inc.K231430親密玫瑰陰道擴張器Plus EV Holdings Dba Intimate Rose K220035米莉陰道擴張器Materna Medical K211959米莉陰道擴張器Materna Medical

官方來源

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