FDA 510(k)

CryoX 液氮凍結凍結組合包 / 解凍組合包

K 號：K223265 · 2023-05-11

申請人Zhejiang Horizon Medical Technology Co., Ltd.

決定日期2023-05-11

產品代碼MQL

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

CryoX Vitrification Freeze Kit / Thaw Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K223265. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CryoX Vitrification Freeze Kit / Thaw Kit?

CryoX Vitrification Freeze Kit / Thaw Kit is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K223265.

When did CryoX Vitrification Freeze Kit / Thaw Kit receive FDA 510(k) clearance?

CryoX Vitrification Freeze Kit / Thaw Kit received FDA 510(k) clearance on 2023-05-11, under 510(k) number K223265.

Who is the listed applicant for CryoX Vitrification Freeze Kit / Thaw Kit?

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

What is the FDA product code for CryoX Vitrification Freeze Kit / Thaw Kit?

The FDA product code for CryoX Vitrification Freeze Kit / Thaw Kit is MQL.

其他以 Zhejiang Horizon Medical Technology Co., 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。

K232163蓮花單腔卵子抽吸針；蓮花雙腔卵子抽吸針

相關器械（代碼：MQL）

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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