FDA 510(k)

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

Número K: K173679 · 2018-07-03

Data da decisão2018-07-03

Código do produtoPEA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes 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 2018-07-03 under 510(k) number K173679. 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 Video Processor with EB Family of Scopes?

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes is a medical device that received FDA 510(k) clearance on 2018-07-03. The listed applicant is Pentax of America, Inc.. The 510(k) number is K173679.

When did PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes receive FDA 510(k) clearance?

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes received FDA 510(k) clearance on 2018-07-03, under 510(k) number K173679.

Who is the listed applicant for PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes?

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 Video Processor with EB Family of Scopes?

The FDA product code for PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes 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.K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.

Fonte oficial

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