HERA W9, HERA W10 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 W9, Hera W10 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK211824
510k NumberK211824
Device Name:HERA W9, HERA W10 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun,  KR 25108
ContactScully Kim
CorrespondentScully Kim
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 Received2021-06-14
Decision Date2021-09-09

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