FDA 510(k)

Philips IntelliSite Pathology Solution

K-Number: K192259 · 2019-09-20

ApplicantPhilips Electronics Nederland B.V.

Decision Date2019-09-20

Product CodePSY

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Philips IntelliSite Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Philips Electronics Nederland B.V.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192259. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips IntelliSite Pathology Solution?

Philips IntelliSite Pathology Solution is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Philips Electronics Nederland B.V.. The 510(k) number is K192259.

When did Philips IntelliSite Pathology Solution receive FDA 510(k) clearance?

Philips IntelliSite Pathology Solution received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192259.

Who is the listed applicant for Philips IntelliSite Pathology Solution?

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

What is the FDA product code for Philips IntelliSite Pathology Solution?

The FDA product code for Philips IntelliSite Pathology Solution is PSY.

Other records listing Philips Electronics Nederland B.V. as applicant

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.

K171055Philips BlueControl

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.