FDA 510(k)

Geri胚胎培養箱搭配Geri Connect及Geri評估軟體，以及Geri盤

K 號：K180188 · 2018-06-07

決定日期2018-06-07

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

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is the device name listed in this FDA 510(k) record. The listed applicant is Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K180188. 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 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K180188.

When did Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish receive FDA 510(k) clearance?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish received FDA 510(k) clearance on 2018-06-07, under 510(k) number K180188.

Who is the listed applicant for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

The FDA 510(k) record lists Genea Biomedx Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

The FDA product code for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is MQG.

其他以 Genea Biomedx 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。

K180304Geri胚胎培養箱及Geri盤 K171736Geri胚胎培養箱及Geri盤 K170498Gems 卵母細胞回收緩冲液 ORB-20，ORB-50 K162409Gems 經濟凝固組合，Gems 加熱組合 K161261Gems 老化中間培養基，Gems 繁殖中間培養基，Gems 裂解中間培養基，Gems 細胞胚胎中間培養基，Gems VitBase

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.K173264胚胎視窗+Vitrolife A/S K180304Geri胚胎培養箱及Geri盤Genea Biomedx Pty, Ltd.

官方來源

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