Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K112911 |
Device Name |
FETAL DOPPLER |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
Diana Hong |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 10/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|