HS30 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 Hs30 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK202556
510k NumberK202556
Device Name:HS30 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 Received2020-09-03
Decision Date2020-10-30

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