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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 echo, ultrasonic
510(K) Number K122574
Device Name DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
Applicant
EDAN INSTRUMENTS, INC.
equipments park, nanhai rd
1019 no. shekou nanshan
shenzhen, 
Contact randy jiang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/23/2012
Decision Date 10/12/2012
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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