Radiographic System Challenge X

System, X-ray, Stationary

Sedecal, SA.

The following data is part of a premarket notification filed by Sedecal, Sa. with the FDA for Radiographic System Challenge X.

Pre-market Notification Details

Device IDK202293
510k NumberK202293
Device Name:Radiographic System Challenge X
ClassificationSystem, X-ray, Stationary
Applicant Sedecal, SA. C/ Pelaya, 9 -13 Pol. Ind. Rio De Janeiro Algete,  ES 28110
ContactMª Luisa Gómez De Agüero
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-13
Decision Date2020-10-07

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