HS50 Diagnostic Ultrasound System, HS60 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 Hs50 Diagnostic Ultrasound System, Hs60 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK210068
510k NumberK210068
Device Name:HS50 Diagnostic Ultrasound System, HS60 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 Received2021-01-11
Decision Date2021-04-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809725795466 K210068 000
08809725795282 K210068 000
08809725795107 K210068 000
08809725794926 K210068 000
08809725794742 K210068 000
08809725794568 K210068 000
08809725782732 K210068 000
08809725782350 K210068 000

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