FDA 510(k)

RI Witness 胚胎學加熱板

K 號：K160504 · 2016-07-18

決定日期2016-07-18

產品代碼MQG

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

RI Witness Embryology Heated Plate 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 2016-07-18 under 510(k) number K160504. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RI Witness Embryology Heated Plate?

RI Witness Embryology Heated Plate is a medical device that received FDA 510(k) clearance on 2016-07-18. The listed applicant is Research Instruments Limited. The 510(k) number is K160504.

When did RI Witness Embryology Heated Plate receive FDA 510(k) clearance?

RI Witness Embryology Heated Plate received FDA 510(k) clearance on 2016-07-18, under 510(k) number K160504.

Who is the listed applicant for RI Witness Embryology Heated Plate?

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 RI Witness Embryology Heated Plate?

The FDA product code for RI Witness Embryology Heated Plate is MQG.

其他以 Research Instruments Limited 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。

K161275EZ-Tip單品，EZ-Tip 20ml瓶，EZ-Grip

相關器械（代碼：MQG）

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。

K261083華萊士® 吸引泵（WAPV1）；華萊士® 泵過濾連接器（WFC）；華萊士® 真空連接組合套件（WVCK）CooperSurgical, Inc.K260194真空泵（型號：AD-VPUM-500）Sheng Sheng Yi (Beijing) Technology Company Limited K242684哈里歐文化TL-16 時間攝影培養箱Hua Yue Medical Technology Co., Ltd.K232493胚胎實時培養箱（TLS301），胚胎實時培養皿（MC 2004）Wuhan Huchuang Union Technology Co., Ltd.K180188Geri胚胎培養箱搭配Geri Connect及Geri評估軟體，以及Geri盤Genea Biomedx Pty, Ltd.K173264胚胎視窗+Vitrolife A/S

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。