RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Samsung Medison Co., Ltd.

The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Rs85 Diagnostic Ultrasound System, Rs80 Evo Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK221117
510k NumberK221117
Device Name:RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KR 25108
ContactJee Young Ju
CorrespondentJee Young Ju
Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KR 25108
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-18
Decision Date2022-06-17

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