HS50 / 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 / Hs60 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK170493
510k NumberK170493
Device Name:HS50 / HS60 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil, Gangnam-gu Seoul,  KR
ContactJiyeon Cho
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-02-17
Decision Date2017-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167764548 K170493 000
08809702986344 K170493 000
08809702986450 K170493 000
08809702986771 K170493 000
08809702986818 K170493 000
08809702981820 K170493 000
08809702985576 K170493 000
08809702985859 K170493 000
08806167759179 K170493 000
08806167759674 K170493 000
08806167759698 K170493 000
08806167797829 K170493 000

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