Soltus 500

System, X-ray, Mobile

Sedecal., SA.

The following data is part of a premarket notification filed by Sedecal., Sa. with the FDA for Soltus 500.

Pre-market Notification Details

Device IDK192936
501k NumberK192936
Device Name:Soltus 500
ClassificationSystem, X-ray, Mobile
Applicant Sedecal., SA. C/ Pelaya, 9-13 Pol. Ind. Rio De Janerio Algete,  ES 28110
ContactMa Luisa Gomez De Aguero
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-15

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