Goldtrace 胎兒螺旋電極 (FSE) (CNS000004)
K 號：K243291 · 2025-01-17
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決定日期2025-01-17
產品代碼HGP
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
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is the device name listed in this FDA 510(k) record. The listed applicant is Neoventa Medical AB. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243291. The device is classified under product code HGP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Neoventa Medical AB. The 510(k) number is K243291.
When did Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) receive FDA 510(k) clearance?
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243291.
Who is the listed applicant for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?
The FDA 510(k) record lists Neoventa Medical AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?
The FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is HGP.
相關臨床試驗
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官方來源
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