FDA 510(k)

翻轉潤滑劑

K 號：K171516 · 2018-02-05

決定日期2018-02-05

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

Flip Lube is the device name listed in this FDA 510(k) record. The listed applicant is Imquest Biosciences, Inc.. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K171516. 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 Flip Lube?

Flip Lube is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Imquest Biosciences, Inc.. The 510(k) number is K171516.

When did Flip Lube receive FDA 510(k) clearance?

Flip Lube received FDA 510(k) clearance on 2018-02-05, under 510(k) number K171516.

Who is the listed applicant for Flip Lube?

The FDA 510(k) record lists Imquest Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flip Lube?

The FDA product code for Flip Lube is NUC.

相關器械（代碼：NUC）

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