LaborView™ LV1000 電極無線系統
K 號：K190798 · 2020-09-18
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決定日期2020-09-18
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
LaborView™ LV1000 Wireless Electrode System is the device name listed in this FDA 510(k) record. The listed applicant is Obmedical Company. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K190798. 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 LaborView™ LV1000 Wireless Electrode System?
LaborView™ LV1000 Wireless Electrode System is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Obmedical Company. The 510(k) number is K190798.
When did LaborView™ LV1000 Wireless Electrode System receive FDA 510(k) clearance?
LaborView™ LV1000 Wireless Electrode System received FDA 510(k) clearance on 2020-09-18, under 510(k) number K190798.
Who is the listed applicant for LaborView™ LV1000 Wireless Electrode System?
The FDA 510(k) record lists Obmedical Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LaborView™ LV1000 Wireless Electrode System?
The FDA product code for LaborView™ LV1000 Wireless Electrode System 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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