G210 InviCell Plus 配合 SignipHy 酸鹼值監測
K 號：K191020 · 2020-01-14
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決定日期2020-01-14
產品代碼PUB
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
G210 InviCell Plus with SignipHy pH monitoring is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K191020. The device is classified under product code PUB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the G210 InviCell Plus with SignipHy pH monitoring?
G210 InviCell Plus with SignipHy pH monitoring is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K191020.
When did G210 InviCell Plus with SignipHy pH monitoring receive FDA 510(k) clearance?
G210 InviCell Plus with SignipHy pH monitoring received FDA 510(k) clearance on 2020-01-14, under 510(k) number K191020.
Who is the listed applicant for G210 InviCell Plus with SignipHy pH monitoring?
FDA 510(k) 記錄將 CooperSurgical, Inc. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for G210 InviCell Plus with SignipHy pH monitoring?
The FDA product code for G210 InviCell Plus with SignipHy pH monitoring is PUB.
相關臨床試驗
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。
其他以 CooperSurgical, Inc. 為申請人之記錄
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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