PLANMED SOPHIE NUANCE CLASSIC— 510(k) K042671

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K042671 for PLANMED SOPHIE NUANCE CLASSIC, Substantially Equivalent on 2004-11-19. Applicant: Planmed OY.

Clearance details

Applicant: Planmed OY
Product code: Code IZH
Advisory panel: Radiology
Date received: 2004-09-29
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

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