FDA 510(k)

C-beam

N.º K: K252735 · 2026-05-22

Fecha de decisión2026-05-22

Código de productoOWB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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)

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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.

Fuente oficial

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