FDA 510(k)

水溶性個人潤滑劑

K 號：K212104 · 2021-11-18

申請人Foshan Pingchuang Medical Technology Co., Ltd.

決定日期2021-11-18

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

Water-soluble Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K212104. 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 Water-soluble Personal Lubricant?

Water-soluble Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. The 510(k) number is K212104.

When did Water-soluble Personal Lubricant receive FDA 510(k) clearance?

Water-soluble Personal Lubricant received FDA 510(k) clearance on 2021-11-18, under 510(k) number K212104.

Who is the listed applicant for Water-soluble Personal Lubricant?

The FDA 510(k) record lists Foshan Pingchuang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Water-soluble Personal Lubricant?

The FDA product code for Water-soluble Personal Lubricant is NUC.

其他以 Foshan Pingchuang Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：NUC）

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