ACCUVIX V10 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 V10 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK070813
510k NumberK070813
Device Name:ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON CO., LTD. 1003, DAECHI-DONG GANGNANM-GU Seoul,  KR 135-280
ContactKyung-am Shim
Product CodeIYN  
Subsequent Product CodeIYO
Subsequent Product CodeIYX
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-03-26
Decision Date2007-04-10
Summary:summary

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