FONA XDC

Unit, X-ray, Extraoral With Timer

FONA S.r.l

The following data is part of a premarket notification filed by Fona S.r.l with the FDA for Fona Xdc.

Pre-market Notification Details

Device IDK222274
510k NumberK222274
Device Name:FONA XDC
ClassificationUnit, X-ray, Extraoral With Timer
Applicant FONA S.r.l Via G.Galilei 11 Assago,  IT 20057
ContactLuigi Germano
CorrespondentKrupa Srivastava
FONA S.r.l Via G.Galilei 11 Assago,  IT 20057
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-08-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E3159319001700 K222274 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.