Natureplex 溫暖觸感加熱膠
K 號：K180828 · 2018-12-20
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決定日期2018-12-20
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
Natureplex Warm Touch Warming Jelly is the device name listed in this FDA 510(k) record. The listed applicant is Natureplex, LLC. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K180828. 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 Natureplex Warm Touch Warming Jelly?
Natureplex Warm Touch Warming Jelly is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Natureplex, LLC. The 510(k) number is K180828.
When did Natureplex Warm Touch Warming Jelly receive FDA 510(k) clearance?
Natureplex Warm Touch Warming Jelly received FDA 510(k) clearance on 2018-12-20, under 510(k) number K180828.
Who is the listed applicant for Natureplex Warm Touch Warming Jelly?
The FDA 510(k) record lists Natureplex, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Natureplex Warm Touch Warming Jelly?
The FDA product code for Natureplex Warm Touch Warming Jelly is NUC.
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相關器械（代碼：NUC）
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官方來源
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