PLANMED SOPHIE, PLANMED SOPHIE CLASSIC— 510(k) K010116

Name: FDA 510(k) clearance K010116
Creator: U.S. Food and Drug Administration
Published: 2001-03-15

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K010116 for PLANMED SOPHIE, PLANMED SOPHIE CLASSIC, Substantially Equivalent on 2001-03-15. 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: 2001-01-16
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, 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.