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FDA 510(k)

Cardiac Workstation (5000); Cardiac Workstation (7000)

K-Number: K241556 · 2024-12-17

ApplicantPhilips Medizin Systeme Böblingen GmbH
Decision Date2024-12-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241556.

When was Cardiac Workstation (5000); Cardiac Workstation (7000) approved by the FDA?

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

What company makes Cardiac Workstation (5000); Cardiac Workstation (7000)?

Cardiac Workstation (5000); Cardiac Workstation (7000) is manufactured by Philips Medizin Systeme Böblingen GmbH.

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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Official Source

View on FDA Database →

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

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