Acessa ProVu 系統
K 號：K181124 · 2018-09-28
廣告
決定日期2018-09-28
產品代碼HFG
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
Acessa ProVu System is the device name listed in this FDA 510(k) record. The listed applicant is Acessa Health, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181124. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Acessa ProVu System?
Acessa ProVu System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Acessa Health, Inc.. The 510(k) number is K181124.
When did Acessa ProVu System receive FDA 510(k) clearance?
Acessa ProVu System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181124.
Who is the listed applicant for Acessa ProVu System?
The FDA 510(k) record lists Acessa Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acessa ProVu System?
The FDA product code for Acessa ProVu System is HFG.
相關臨床試驗
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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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