System, Image Processing, Radiological

Software Nemotec S.L.

The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemofab.

Pre-market Notification Details

Device IDK192475
510k NumberK192475
Device Name:NemoFAB
ClassificationSystem, Image Processing, Radiological
Applicant Software Nemotec S.L. Juan De La Cierva Street, 66 Arroyomolinos, Madrid,  ES 28939
ContactCarlos Arias
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-10
Decision Date2020-04-23

© 2020
This site is not affiliated with or endorsed by the FDA.