PLANMED SOPHIE & PLANMED SOPHIE CLASSIC— 510(k) K013656

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K013656 for PLANMED SOPHIE & PLANMED SOPHIE CLASSIC, Substantially Equivalent on 2002-01-16. Applicant: Planmed OY.

Clearance details

Applicant: Planmed OY
Product code: Code IZH
Advisory panel: Radiology
Date received: 2001-11-06
Decision date: 2002-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, IL, US

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