Pusen Eview Medical Video Endoscope Image Processor
K-Number: K190648 · 2019-03-29
Decision Date2019-03-29
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Pusen Eview Medical Video Endoscope Image Processor is a medical device manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-03-29 under approval number K190648. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pusen Eview Medical Video Endoscope Image Processor?
Pusen Eview Medical Video Endoscope Image Processor is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K190648.
When was Pusen Eview Medical Video Endoscope Image Processor approved by the FDA?
Pusen Eview Medical Video Endoscope Image Processor received FDA 510(k) clearance on 2019-03-29, under approval number K190648.
What company makes Pusen Eview Medical Video Endoscope Image Processor?
Pusen Eview Medical Video Endoscope Image Processor is manufactured by Zhuhai Pusen Medical Technology Co., Ltd..
What is the FDA product code for Pusen Eview Medical Video Endoscope Image Processor?
The FDA product code for Pusen Eview Medical Video Endoscope Image Processor is FET.
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Other Devices by Zhuhai Pusen Medical Technology Co., Ltd.
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K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.