HM70 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 Hm70 Evo Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK220269
510k NumberK220269
Device Name:HM70 EVO Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KP 25108
ContactJu Jee Young
CorrespondentJee Young Ju
Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KP 25108
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-05-06

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