RS85 Diagnostic Ultrasound System, RS80 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 Rs85 Diagnostic Ultrasound System, Rs80 Evo Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK210959
510k NumberK210959
Device Name:RS85 Diagnostic Ultrasound System, RS80 EVO 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 Received2021-03-31
Decision Date2021-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809725805363 K210959 000

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