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
510k 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08436046002463 K192936 000
08436046002456 K192936 000
08436046002449 K192936 000
08436046002562 K192936 000
08436046002555 K192936 000
08436046002548 K192936 000
08436046002531 K192936 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.