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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 # Shekou Nanshan
Shenzhen, Guangdong,  CN 518067
Applicant Contact RANDY JIANG
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/23/2012
Decision Date 10/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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