PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)— 510(k) K021945

Name: FDA 510(k) clearance K021945
Creator: U.S. Food and Drug Administration
Published: 2003-02-21

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K021945 for PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE), Substantially Equivalent on 2003-02-21. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2002-06-13
Decision date: 2003-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.