FDA 510(k)

JO for Him H2O Gel 原味個人潤滑劑

K 號：K192203 · 2020-02-10

決定日期2020-02-10

產品代碼NUC

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

JO for Him H2O Gel Original Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K192203. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JO for Him H2O Gel Original Personal Lubricant?

JO for Him H2O Gel Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is United Consortium. The 510(k) number is K192203.

When did JO for Him H2O Gel Original Personal Lubricant receive FDA 510(k) clearance?

JO for Him H2O Gel Original Personal Lubricant received FDA 510(k) clearance on 2020-02-10, under 510(k) number K192203.

Who is the listed applicant for JO for Him H2O Gel Original Personal Lubricant?

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

What is the FDA product code for JO for Him H2O Gel Original Personal Lubricant?

The FDA product code for JO for Him H2O Gel Original Personal Lubricant is NUC.

其他以 United Consortium 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。

K190858Bucked Stride矽膠潤滑劑，#LubeLife薄型矽膠潤滑劑，JO XTRA SILKY超薄型矽膠個人潤滑劑 K191214JO 頂級果凍原味個人潤滑劑 K182585JO積極試用個人潤滑劑 K183584JO H2O 舒適保濕原味個人潤滑劑 K183384JO Agape 原創個人潤滑劑，MUSE Essence 水基潤滑劑，#LubeLife 水基潤滑劑，#LubeLife 水基肛交潤滑劑 K182105JO自然愛個人潤滑劑，JO自然愛草莓園口味個人潤滑劑

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相關器械（代碼：NUC）

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。

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官方來源

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