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FDA 510(k)

Brain Perfusion (BP) application

K-Number: K201573 · 2021-08-17

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2021-08-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brain Perfusion (BP) application is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-08-17 under approval number K201573. 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 Brain Perfusion (BP) application?

Brain Perfusion (BP) application is a medical device that received FDA 510(k) clearance on 2021-08-17. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K201573.

When was Brain Perfusion (BP) application approved by the FDA?

Brain Perfusion (BP) application received FDA 510(k) clearance on 2021-08-17, under approval number K201573.

What company makes Brain Perfusion (BP) application?

Brain Perfusion (BP) application is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Brain Perfusion (BP) application?

The FDA product code for Brain Perfusion (BP) application 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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