FDA 510(k)

親密玫瑰陰道擴張器

K 號：K231430 · 2023-06-07

決定日期2023-06-07

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

Intimate Rose Vaginal Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K231430. 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 Intimate Rose Vaginal Dilators?

Intimate Rose Vaginal Dilators is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Plus EV Holdings Dba Intimate Rose. The 510(k) number is K231430.

When did Intimate Rose Vaginal Dilators receive FDA 510(k) clearance?

Intimate Rose Vaginal Dilators received FDA 510(k) clearance on 2023-06-07, under 510(k) number K231430.

Who is the listed applicant for Intimate Rose Vaginal Dilators?

The FDA 510(k) record lists Plus EV Holdings Dba Intimate Rose as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intimate Rose Vaginal Dilators?

The FDA product code for Intimate Rose Vaginal Dilators is HDX.

其他以 Plus EV Holdings Dba Intimate Rose 為申請人之記錄

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 K193364親密玫瑰骨盆腔練習系統

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.K222492希望&她陰道擴張器Lujena, Inc.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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