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FDA 510(k)

Brain Perfusion (BP) application

K-Number: K182716 · 2019-05-29

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2019-05-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brain Perfusion (BP) application 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 2019-05-29 under 510(k) number K182716. The device is classified under product code JAK. 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 2019-05-29. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K182716.

When did Brain Perfusion (BP) application receive FDA 510(k) clearance?

Brain Perfusion (BP) application received FDA 510(k) clearance on 2019-05-29, under 510(k) number K182716.

Who is the listed applicant for Brain Perfusion (BP) application?

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 Brain Perfusion (BP) application?

The FDA product code for Brain Perfusion (BP) application is JAK.

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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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