PUREtrace™
K 號：K153262 · 2017-02-07
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決定日期2017-02-07
產品代碼OSP
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
PUREtrace™ is the device name listed in this FDA 510(k) record. The listed applicant is Nemo Healthcare BV. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K153262. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PUREtrace™?
PUREtrace™ is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Nemo Healthcare BV. The 510(k) number is K153262.
When did PUREtrace™ receive FDA 510(k) clearance?
PUREtrace™ received FDA 510(k) clearance on 2017-02-07, under 510(k) number K153262.
Who is the listed applicant for PUREtrace™?
The FDA 510(k) record lists Nemo Healthcare BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PUREtrace™?
The FDA product code for PUREtrace™ is OSP.
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相關器械（代碼：OSP）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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