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 IDK143089
510k NumberK143089
Device Name:WS80A Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL Gangnam-gu,  KR
ContactPark Kyeong-mi
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 Received2014-10-28
Decision Date2014-11-26
Summary:summary

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