WS80A 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 Ws80a Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK173513
510k NumberK173513
Device Name:WS80A Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul,  KR 06176
ContactJi Yea Lee
CorrespondentJi Yea Lee
Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul,  KR 06176
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-13
Decision Date2018-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167780081 K173513 000

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