FDA 510(k)

LS OIL

Número K: K173920 · 2018-10-11

Data da decisão2018-10-11

Código do produtoEKX

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

LS OIL is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K173920. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LS OIL?

LS OIL is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K173920.

When did LS OIL receive FDA 510(k) clearance?

LS OIL received FDA 510(k) clearance on 2018-10-11, under 510(k) number K173920.

Who is the listed applicant for LS OIL?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LS OIL?

The FDA product code for LS OIL is EKX.

Outros registros que listam J. Morita USA, Inc. 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.

K213477Root ZX3 K201378Accuitomo 150N 3D K190509Lubrina 2 K171012Veraview X800 K170275Tri Auto ZX2

Dispositivos Relacionados (Código: EKX)

K261987Reusable SmartPegOsstell AB K252223Mão de Ferramentas de Endodontia Alpha (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.