Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K150045 |
Device Name |
S30/S40 Digital Color Doppler Ultraound System |
Applicant |
SONOSCAPE COMPANY LIMITED |
YIZHE BLDG, YUQUAN ROAD |
NANSHAN DISTRICT |
SHENZHEN, GUANGDONG,
CN
518051
|
|
Applicant Contact |
TOKI WU |
Correspondent |
SONOSCAPE COMPANY LIMITED |
YIZHE BLDG, YUQUAN ROAD |
NANSHAN DISTRICT |
SHENZHEN, GUANGDONG,
CN
518051
|
|
Correspondent Contact |
TOKI WU |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/12/2015 |
Decision Date | 04/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|