Spectra 9Plus
K 號：K162415 · 2017-03-15
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決定日期2017-03-15
產品代碼HGX
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
Spectra 9Plus is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Company. It received FDA 510(k) clearance on 2017-03-15 under 510(k) number K162415. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Spectra 9Plus?
Spectra 9Plus is a medical device that received FDA 510(k) clearance on 2017-03-15. The listed applicant is Uzinmedicare Company. The 510(k) number is K162415.
When did Spectra 9Plus receive FDA 510(k) clearance?
Spectra 9Plus received FDA 510(k) clearance on 2017-03-15, under 510(k) number K162415.
Who is the listed applicant for Spectra 9Plus?
The FDA 510(k) record lists Uzinmedicare Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spectra 9Plus?
The FDA product code for Spectra 9Plus is HGX.
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相關器械（代碼：HGX）
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官方來源
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