T-Lite

System, Imaging, Pulsed Doppler, Ultrasonic

Sonoscanner

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

Pre-market Notification Details

Device IDK201988
510k NumberK201988
Device Name:T-Lite
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Sonoscanner 6 Rue Andre Voguet Ivry Sur Seine,  FR 94200
ContactBruno Richard
CorrespondentE.j. Smith
Smith Assoicates 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 Received2020-07-17
Decision Date2020-10-30

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