FDA 510(k)

Zenition 30

Número K: K254205 · 2026-08-07

RequerentePhilips Medical Systems Nederland B.V.

Data da decisão2026-08-07

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zenition 30 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K254205. 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 Zenition 30?

Zenition 30 is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K254205.

When did Zenition 30 receive FDA 510(k) clearance?

Zenition 30 received FDA 510(k) clearance on 2026-08-07, under 510(k) number K254205.

Who is the listed applicant for Zenition 30?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenition 30?

The FDA product code for Zenition 30 is OWB.

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Fonte oficial

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