Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K122710 |
Device Name |
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND |
Applicant |
SHENZHEN DELICATE ELECTRONICS CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHENZHEN DELICATE ELECTRONICS CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2012 |
Decision Date | 02/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|