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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K251215.

When did Philips IntelliSpace Cardiovascular receive FDA 510(k) clearance?

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

Who is the listed applicant for Philips IntelliSpace Cardiovascular?

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

What is the FDA product code for Philips IntelliSpace Cardiovascular?

The FDA product code for Philips IntelliSpace Cardiovascular is LLZ.

Other records listing Philips Medical Systems Nederland B.V. as applicant

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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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