FDA 510(k)

C-beam

K-Number: K252735 · 2026-05-22

Decision Date2026-05-22

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.