FDA 510(k)

EZ-Tip單品，EZ-Tip 20ml瓶，EZ-Grip

K 號：K161275 · 2017-01-23

決定日期2017-01-23

產品代碼MQH

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

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip is the device name listed in this FDA 510(k) record. The listed applicant is Research Instruments Limited. It received FDA 510(k) clearance on 2017-01-23 under 510(k) number K161275. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip?

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip is a medical device that received FDA 510(k) clearance on 2017-01-23. The listed applicant is Research Instruments Limited. The 510(k) number is K161275.

When did EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip receive FDA 510(k) clearance?

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip received FDA 510(k) clearance on 2017-01-23, under 510(k) number K161275.

Who is the listed applicant for EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip?

The FDA 510(k) record lists Research Instruments Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip?

The FDA product code for EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip is MQH.

其他以 Research Instruments Limited 為申請人之記錄

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K160504RI Witness 胚胎學加熱板

相關器械（代碼：MQH）

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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