PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

System, X-ray, Mammographic

PLANMED OY

The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Sophie & Planned Sophie Classic.

Pre-market Notification Details

Device IDK983659
510k NumberK983659
Device Name:PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
ClassificationSystem, X-ray, Mammographic
Applicant PLANMED OY ASENTAJANKATU 6 Helsinki,  FI 00880
ContactLars Moring
CorrespondentLars Moring
PLANMED OY ASENTAJANKATU 6 Helsinki,  FI 00880
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-19
Decision Date1998-11-16

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