FDA 510(k)

ARTSMedia 室內培養培養基 (AM-IVC 培養基)

K 號：K220715 · 2023-02-10

決定日期2023-02-10

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

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is the device name listed in this FDA 510(k) record. The listed applicant is Artsmedia Denmark Aps. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K220715. 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 ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Artsmedia Denmark Aps. The 510(k) number is K220715.

When did ARTSMedia In Vitro Culture Medium (AM-IVC Medium) receive FDA 510(k) clearance?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K220715.

Who is the listed applicant for ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

The FDA 510(k) record lists Artsmedia Denmark Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

The FDA product code for ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is MQL.

其他以 Artsmedia Denmark Aps 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。

K241095ARTSMedia 精子洗滌培養基 K241132ARTSMedia 卵母細胞抽吸培養基 (502020, 502050, 502100)

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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