EKO 7 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 Eko 7 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK101455
510k NumberK101455
Device Name:EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON CO., LTD. 1003 DAECHI-DONG GANGNAM-GU Seoul,  KR 135-280
ContactKyung-am Shim
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 Received2010-05-25
Decision Date2010-07-19
Summary:summary

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