U-Lite EXP

System, Imaging, Pulsed Doppler, Ultrasonic

Sonoscanner

The following data is part of a premarket notification filed by Sonoscanner with the FDA for U-lite Exp.

Pre-market Notification Details

Device IDK171164
510k NumberK171164
Device Name:U-Lite EXP
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Sonoscanner 6 Rue Andre Voguet Ivry Sur Seine,  FR 94200
ContactBruno Richard
CorrespondentE. J. Smith
Smith Associates 1468 Harwell Avenue Crofton,  MD  21114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-20
Decision Date2017-08-03
Summary:summary

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