FDA 510(k)

Pusen Eview Medical Video Endoscope Image Processor

Número K: K190648 · 2019-03-29

RequerenteZhuhai Pusen Medical Technology Co., Ltd.

Data da decisão2019-03-29

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pusen Eview Medical Video Endoscope Image Processor is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K190648. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K190648.

When did Pusen Eview Medical Video Endoscope Image Processor receive FDA 510(k) clearance?

Pusen Eview Medical Video Endoscope Image Processor received FDA 510(k) clearance on 2019-03-29, under 510(k) number K190648.

Who is the listed applicant for Pusen Eview Medical Video Endoscope Image Processor?

The FDA 510(k) record lists Zhuhai Pusen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Zhuhai Pusen Medical Technology Co., Ltd. como candidato(a)

K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)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)K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)K172098Medical Video Endoscope System K171076Medical Video Endoscope System

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Fonte oficial

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