FDA 510(k)

Philips VSC-MEDlib

Número K: K242001 · 2025-04-04

RequerentePhilips Medical Systems Nederland B.V.

Data da decisão2025-04-04

Código do produtoBZQ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips VSC-MEDlib 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 2025-04-04 under 510(k) number K242001. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips VSC-MEDlib?

Philips VSC-MEDlib is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K242001.

When did Philips VSC-MEDlib receive FDA 510(k) clearance?

Philips VSC-MEDlib received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242001.

Who is the listed applicant for Philips VSC-MEDlib?

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 Philips VSC-MEDlib?

The FDA product code for Philips VSC-MEDlib is BZQ.

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