FDA 510(k)

Cardiac Workstation (5000); Cardiac Workstation (7000)

Número K: K241556 · 2024-12-17

RequerentePhilips Medizin Systeme Böblingen GmbH

Data da decisão2024-12-17

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardiac Workstation (5000); Cardiac Workstation (7000) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241556. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardiac Workstation (5000); Cardiac Workstation (7000)?

Cardiac Workstation (5000); Cardiac Workstation (7000) is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241556.

When did Cardiac Workstation (5000); Cardiac Workstation (7000) receive FDA 510(k) clearance?

Cardiac Workstation (5000); Cardiac Workstation (7000) received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241556.

Who is the listed applicant for Cardiac Workstation (5000); Cardiac Workstation (7000)?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardiac Workstation (5000); Cardiac Workstation (7000)?

The FDA product code for Cardiac Workstation (5000); Cardiac Workstation (7000) is DPS.

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Fonte oficial

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