NewTom 7G

System, X-ray, Tomography, Computed

CEFLA S.C.

The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Newtom 7g.

Pre-market Notification Details

Device IDK220664
510k NumberK220664
Device Name:NewTom 7G
ClassificationSystem, X-ray, Tomography, Computed
Applicant CEFLA S.C. Via Selice Prov.le 23/ Imola,  IT 40026
ContactLorenzo Bortolotti
CorrespondentLorenzo Bortolotti
CEFLA S.C. Via Selice Prov.le 23/ Imola,  IT 40026
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-05-06

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