FDA 510(k)

IntelliSpace Portal Platform

Número K: K162025 · 2016-10-18

RequerentePhilips Medical Systems Nederlands B.V.

Data da decisão2016-10-18

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

IntelliSpace Portal Platform is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162025. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IntelliSpace Portal Platform?

IntelliSpace Portal Platform is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K162025.

When did IntelliSpace Portal Platform receive FDA 510(k) clearance?

IntelliSpace Portal Platform received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162025.

Who is the listed applicant for IntelliSpace Portal Platform?

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

What is the FDA product code for IntelliSpace Portal Platform?

The FDA product code for IntelliSpace Portal Platform is LLZ.

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Fonte oficial

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