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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 K121937
Device Name E-CUBE INNO
Original Applicant
ALPINION MEDICAL SYSTEMS CO., LTD
1, 6 and 7fl, verdi tower
72, digital-ro(st) 26-gil(rd) guro-gu
seoul,  KR 152-848
Original Contact donghwan kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/02/2012
Decision Date 07/26/2012
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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