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FDA 510(k)

Philips IntelliSpace Cardiovascular

K-Number: K251215 · 2025-10-02

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2025-10-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips IntelliSpace Cardiovascular is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-10-02 under approval number K251215. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips IntelliSpace Cardiovascular?

Philips IntelliSpace Cardiovascular is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K251215.

When was Philips IntelliSpace Cardiovascular approved by the FDA?

Philips IntelliSpace Cardiovascular received FDA 510(k) clearance on 2025-10-02, under approval number K251215.

What company makes Philips IntelliSpace Cardiovascular?

Philips IntelliSpace Cardiovascular is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Philips IntelliSpace Cardiovascular?

The FDA product code for Philips IntelliSpace Cardiovascular is LLZ.

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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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