FDA 510(k)

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

Número K: K191282 · 2019-11-08

Data da decisão2019-11-08

Código do produtoPEA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191282. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Pentax of America, Inc.. The 510(k) number is K191282.

When did PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family receive FDA 510(k) clearance?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191282.

Who is the listed applicant for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is PEA.

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Outros registros que listam Pentax of America, Inc. como candidato(a)

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K251127PENTAX Medical Video Processor (EPK-i8020c)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

Ver todos os 39 dispositivos →

Dispositivos Relacionados (Código: PEA)

K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPentax of America, Inc.K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.

Fonte oficial

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