SmartUs EXT-1M/3M

System, Imaging, Pulsed Doppler, Ultrasonic

TELEMED

The following data is part of a premarket notification filed by Telemed with the FDA for Smartus Ext-1m/3m.

Pre-market Notification Details

Device IDK163121
510k NumberK163121
Device Name:SmartUs EXT-1M/3M
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant TELEMED DARIAUS IR GIRENO STR.42 Vilnius,  LT Lt-02189
ContactYury Sokolov
CorrespondentYury Sokolov
TELEMED DARIAUS IR GIRENO STR.42 Vilnius,  LT Lt-02189
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-08
Decision Date2017-08-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04772057000246 K163121 000
04772057000239 K163121 000
04772057000222 K163121 000
04772057000208 K163121 000
04772057000192 K163121 000
04772057000178 K163121 000
04772057000161 K163121 000
04772057000154 K163121 000

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