ACCUVIX V7 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 V7 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK060087
510k NumberK060087
Device Name:ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON CO., LTD. 997-10 DAECHI-DONG GUANGNAM-G Seoul,  KR 135-280
ContactKyung-am Shim
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-01-12
Decision Date2006-01-24
Summary:summary

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