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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
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 Number892.1550
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
Predetermined Change
Control Plan Authorized		 No
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