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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 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.

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. 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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Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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