Planmed Verity

X-ray, Tomography, Computed, Dental

Planmed Oy

The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Verity.

Pre-market Notification Details

Device IDK213278
510k NumberK213278
Device Name:Planmed Verity
ClassificationX-ray, Tomography, Computed, Dental
Applicant Planmed Oy Sorvaajankatu 7 Helsinki,  FI 00880
ContactNiina Vuorikallas
CorrespondentNiina Vuorikallas
Planmed Oy Sorvaajankatu 7 Helsinki,  FI 00880
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-01
Decision Date2022-04-28

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