ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

MEDISON CO., LTD.

The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Accuvix V20 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK080800
510k NumberK080800
Device Name:ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON CO., LTD. 1003, DAECHI-DONG GANGNAM-GU Seoul,  KR 135-280
ContactShim Kyung-am
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 Received2008-03-21
Decision Date2008-04-07
Summary:summary

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