FDA 510(k)

C-beam

Número K: K252735 · 2026-05-22

Data da decisão2026-05-22

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

C-beam is the device name listed in this FDA 510(k) record. The listed applicant is Pulmera, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252735. 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 C-beam?

C-beam is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Pulmera, Inc.. The 510(k) number is K252735.

When did C-beam receive FDA 510(k) clearance?

C-beam received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252735.

Who is the listed applicant for C-beam?

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

What is the FDA product code for C-beam?

The FDA product code for C-beam 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.K252503Intelligent NRCanon, 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.