Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K152543 |
Device Name |
M9/M9CV/M9T Diagnostic Ultrasound System |
Applicant |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Keji 12th Road South, Hi-tech Industrial Park, Nanshan |
HI-TECH INDUSTRIAL PARK, NANSHAN |
shenzhen,
CN
518057
|
|
Applicant Contact |
wu zicui |
Correspondent |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Keji 12th Road South, Hi-tech Industrial Park, Nanshan |
shenzhen,
CN
518057
|
|
Correspondent Contact |
wu zicui |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2015 |
Decision Date | 10/29/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|