FDA 510(k)

LAP-iX

Número K: K173112 · 2017-11-21

Data da decisão2017-11-21

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LAP-iX is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K173112. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LAP-iX?

LAP-iX is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K173112.

When did LAP-iX receive FDA 510(k) clearance?

LAP-iX received FDA 510(k) clearance on 2017-11-21, under 510(k) number K173112.

Who is the listed applicant for LAP-iX?

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

What is the FDA product code for LAP-iX?

The FDA product code for LAP-iX is GEI.

Outros registros que listam Sejong Medical Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253165LAP-iX2N K252985Laport K200639LAP-iX K200638LAP-iX Suction Irrigation K173108Smoklean K173111LAP-iX Suction Irrigation

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Fonte oficial

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