FDA 510(k)

F3

Número K: K222998 · 2023-06-20

Data da decisão2023-06-20

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

F3 is the device name listed in this FDA 510(k) record. The listed applicant is Acrew Imaging, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K222998. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the F3?

F3 is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Acrew Imaging, Inc.. The 510(k) number is K222998.

When did F3 receive FDA 510(k) clearance?

F3 received FDA 510(k) clearance on 2023-06-20, under 510(k) number K222998.

Who is the listed applicant for F3?

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

What is the FDA product code for F3?

The FDA product code for F3 is OWB.

Dispositivos Relacionados (Código: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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.