ACCUVIX A30 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 Accuvix A30 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK112339
510k NumberK112339
Device Name:ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SAMSUNG MEDISON CO., LTD 1003 DAECHI-DONG, GANGNAM-GU Seoul,  KR 135-280
ContactKyeong-mi Park
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 Received2011-08-15
Decision Date2011-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167700416 K112339 000
08806167700409 K112339 000

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