Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K172993 |
Device Name |
P20 Series Digital Color Doppler Ultrasound System |
Applicant |
Sonoscape Medical Corp. |
4/f, 5/f, 8/f, 9/f & 10/f |
yizhe building, yuquan road, nanshan |
shenzhen,
CN
518051
|
|
Applicant Contact |
Toki Wu |
Correspondent |
Sonoscape Medical Corp. |
4/f, 5/f, 8/f, 9/f & 10/f |
yizhe building, yuquan road, nanshan |
shenzhen,
CN
518051
|
|
Correspondent Contact |
Toki Wu |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/2017 |
Decision Date | 12/05/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|