Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K121729 |
Device Name |
E-CUBE 7 |
Applicant |
ALPINION MEDICAL SYSTEMS CO., LTD |
SUITE 226, 10604 |
NE 38TH PLACE |
KIRKLAND,
WA
98033
|
|
Applicant Contact |
YUCHI CHU |
Correspondent |
ALPINION MEDICAL SYSTEMS CO., LTD |
SUITE 226, 10604 |
NE 38TH PLACE |
KIRKLAND,
WA
98033
|
|
Correspondent Contact |
YUCHI CHU |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/12/2012 |
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
|
|
|