| Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
|---|
| 510(K) Number |
K121888 |
|---|
| Model |
E-CUBE 15
|
| 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,
|
|
| Contact |
donghwan kim |
| Regulation Number | 892.1560
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 06/28/2012 |
|---|
| Decision Date | 07/26/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
