| Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
|---|
| 510(K) Number |
K122010 |
|---|
| Device Name |
Z6 DIAGNOSTIC ULTRASOUND SYSTEM |
|---|
| Applicant |
| SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| mindray building, keji 12th road south |
| hi-tech industrial park, nanshan |
|
shenzhen,
|
|
| Contact |
yang zhaohui |
| Regulation Number | 892.1550
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 07/09/2012 |
|---|
| Decision Date | 07/20/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
Yes
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
