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FDA 510(k)

胚胎實時培養箱（TLS301），胚胎實時培養皿（MC 2004）

K 號：K232493 · 2024-05-07

申請人Wuhan Huchuang Union Technology Co., Ltd.
決定日期2024-05-07
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

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232493. 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 Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. The 510(k) number is K232493.

When did Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) receive FDA 510(k) clearance?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232493.

Who is the listed applicant for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA 510(k) record lists Wuhan Huchuang Union Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is MQG.

相關臨床試驗

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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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。

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官方來源

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