exCellerator 頸部採集設備
K 號：K182049 · 2019-04-25
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決定日期2019-04-25
產品代碼HHT
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
exCellerator Cervical Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Excell Company, LLC. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182049. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the exCellerator Cervical Collection Device?
exCellerator Cervical Collection Device is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Excell Company, LLC. The 510(k) number is K182049.
When did exCellerator Cervical Collection Device receive FDA 510(k) clearance?
exCellerator Cervical Collection Device received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182049.
Who is the listed applicant for exCellerator Cervical Collection Device?
The FDA 510(k) record lists Excell Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for exCellerator Cervical Collection Device?
The FDA product code for exCellerator Cervical Collection Device is HHT.
相關臨床試驗
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相關器械（代碼：HHT）
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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