FDA 510(k)

pjur 女性裸色 pjur med 敏感滑順

K 號：K200730 · 2020-12-17

決定日期2020-12-17

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

pjur WOMAN Nude pjur med SENSITIVE glide is the device name listed in this FDA 510(k) record. The listed applicant is Pjur Group Luxembourg S.A.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K200730. 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 pjur WOMAN Nude pjur med SENSITIVE glide?

pjur WOMAN Nude pjur med SENSITIVE glide is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Pjur Group Luxembourg S.A.. The 510(k) number is K200730.

When did pjur WOMAN Nude pjur med SENSITIVE glide receive FDA 510(k) clearance?

pjur WOMAN Nude pjur med SENSITIVE glide received FDA 510(k) clearance on 2020-12-17, under 510(k) number K200730.

Who is the listed applicant for pjur WOMAN Nude pjur med SENSITIVE glide?

The FDA 510(k) record lists Pjur Group Luxembourg S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pjur WOMAN Nude pjur med SENSITIVE glide?

The FDA product code for pjur WOMAN Nude pjur med SENSITIVE glide is NUC.

其他以 Pjur Group Luxembourg S.A. 為申請人之記錄

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相關器械（代碼：NUC）

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官方來源

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