FDA 510(k)

雙腔卵子吸取針

K 號：K171611 · 2017-12-15

申請人William A. Cook Australia Pty. , Ltd.

決定日期2017-12-15

產品代碼MQE

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

Double Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K171611. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Double Lumen Ovum Aspiration Needles?

Double Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K171611.

When did Double Lumen Ovum Aspiration Needles receive FDA 510(k) clearance?

Double Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2017-12-15, under 510(k) number K171611.

Who is the listed applicant for Double Lumen Ovum Aspiration Needles?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Lumen Ovum Aspiration Needles?

The FDA product code for Double Lumen Ovum Aspiration Needles is MQE.

其他以 William A. Cook Australia Pty. , Ltd. 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。

K173431Towako 轉宮腔胚胎移植組合 K160753COOK 真空泵 K170257悉尼IVF培養油 K153478悉尼IVF卵子緩冲劑 K152717悉尼IVF胚囊冷凍組合包，悉尼IVF胚囊解凍組合包 K160814悉尼IVF精子冷凍保護劑

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相關器械（代碼：MQE）

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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