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 IDK171070
510k NumberK171070
Device Name:WS80A Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul,  KR
ContactEmily Woo
CorrespondentEmily Woo
Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul,  KR
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-10
Decision Date2017-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167780623 K171070 000
08806167780463 K171070 000
08806167780265 K171070 000
08806167765507 K171070 000

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