Philips IntelliSite Pathology Solution— 510(k) K192259

Name: FDA 510(k) clearance K192259
Creator: U.S. Food and Drug Administration
Published: 2019-09-20

Substantially Equivalent

Philips Electronics Nederland B.V.

FDA 510(k) clearance K192259 for Philips IntelliSite Pathology Solution, Substantially Equivalent on 2019-09-20. Applicant: Philips Electronics Nederland B.V.. Device class: 2.

Clearance details

Applicant: Philips Electronics Nederland B.V.
Product code: Code PSY
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2019-08-21
Decision date: 2019-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Best, NL

Download summary PDF View on FDA.gov ↗

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