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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 K121729
Device Name E-CUBE 7
Original Applicant
ALPINION MEDICAL SYSTEMS CO., LTD
suite 226, 10604
ne 38th place
kirkland,  WA  98033
Original Contact yuchi chu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/12/2012
Decision Date 09/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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