智能帶EMR套件，智能帶EMR包，智能夾子
K 號：K190512 · 2019-11-22
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器材摘要
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Endoscopy. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K190512. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Intelligent Endoscopy. The 510(k) number is K190512.
When did SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare receive FDA 510(k) clearance?
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare received FDA 510(k) clearance on 2019-11-22, under 510(k) number K190512.
Who is the listed applicant for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?
The FDA 510(k) record lists Intelligent Endoscopy as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?
The FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is FDI.
相關臨床試驗
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相關器械（代碼：FDI）
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。
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官方來源
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