PLANMED SOPHIE & PLANNED SOPHIE CLASSIC— 510(k) K983659

Name: FDA 510(k) clearance K983659
Creator: U.S. Food and Drug Administration
Published: 1998-11-16

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K983659 for PLANMED SOPHIE & PLANNED SOPHIE CLASSIC, Substantially Equivalent on 1998-11-16. 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: 1998-10-19
Decision date: 1998-11-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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