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 Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/02/2012 |
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
|
|
|