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

Substantially Equivalent

Planmed OY

Clearance details

Applicant
Planmed OY
Product code
Code IZH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Roselle, IL, US
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