FDA 510(k), K190648, Pusen Eview Medical Video Endoscope Image Processor
FDA 510(k), K190648, Pusen Eview Medical Video Endoscope Image Processor
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510(K) Number: K190648
Device Name: Pusen Eview Medical Video Endoscope Image Processor
Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: 876.1500
Classification Product Code: FET
Date Received: 03/13/2019
Decision Date: 03/29/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Pusen Eview Medical Video Endoscope Image Processor
Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: 876.1500
Classification Product Code: FET
Date Received: 03/13/2019
Decision Date: 03/29/2019
Regulation Medical Specialty: Gastroenterology/Urology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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