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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(K) Number K122583
Device Name UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SAMSUNG MEDISON CO., LTD
42, teheran-ro 108-gil
gangnam-gu
seoul, 
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/24/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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