HS40 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 Hs40 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK180409
510k NumberK180409
Device Name:HS40 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co, Ltd. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun Gangwon-do,  KR 25108
ContactJi Yea Lee
CorrespondentJi Yea Lee
Samsung Medison Co, Ltd. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun Gangwon-do,  KR 25108
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-14
Decision Date2018-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167791056 K180409 000
08806167790837 K180409 000
08806167790790 K180409 000
08806167790646 K180409 000
08806167759933 K180409 000
08806167759896 K180409 000
08806167759872 K180409 000
08806167759865 K180409 000
08809702980571 K180409 000

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