Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K183660 |
Device Name |
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System |
Applicant |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Keji 12th Road South, Hi-tech Industrial Park |
Shenzhen,
CN
518057
|
|
Applicant Contact |
Jiang Haosen |
Correspondent |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Keji 12th Road South, Hi-tech Industrial Park |
Shenzhen,
CN
518057
|
|
Correspondent Contact |
Jiang Haosen |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/2018 |
Decision Date | 04/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|