HS70A 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 Hs70a Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK200699
510k NumberK200699
Device Name:HS70A Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KR 25108
ContactJi Yea Lee
CorrespondentJi Yea Lee
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 Received2020-03-17
Decision Date2020-05-07

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.