HERA I10 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 Hera I10 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK190444
510k NumberK190444
Device Name:HERA I10 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 Received2019-02-25
Decision Date2019-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809521022414 K190444 000

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