FDA 510(k)

哈里歐文化TL-16 時間攝影培養箱

K 號：K242684 · 2025-05-22

決定日期2025-05-22

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

Harioculture TL-16 Time-lapse Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Hua Yue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K242684. 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 Harioculture TL-16 Time-lapse Incubator?

Harioculture TL-16 Time-lapse Incubator is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K242684.

When did Harioculture TL-16 Time-lapse Incubator receive FDA 510(k) clearance?

Harioculture TL-16 Time-lapse Incubator received FDA 510(k) clearance on 2025-05-22, under 510(k) number K242684.

Who is the listed applicant for Harioculture TL-16 Time-lapse Incubator?

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

What is the FDA product code for Harioculture TL-16 Time-lapse Incubator?

The FDA product code for Harioculture TL-16 Time-lapse Incubator is MQG.

其他以 Hua Yue 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。

K253333輔助生殖雷射系統（型號ILS-400M）

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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