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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 K121888
Device Name E-CUBE 15
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
Applicant Contact DONGHWAN KIM
Correspondent
ALPINION MEDICAL SYSTEMS CO., LTD
1, 6 AND 7FL, VERDI TOWER
72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU
SEOUL,  KR 152-848
Correspondent Contact DONGHWAN KIM
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received06/28/2012
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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