Device Classification Name |
Monitor, Ultrasonic, Fetal
|
510(k) Number |
K100626 |
Device Name |
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 |
Applicant |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
SUITE 5D, NO 19, LANE 999 |
ZHONGSHAN NO. 2 ROAD(S) |
SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
SUITE 5D, NO 19, LANE 999 |
ZHONGSHAN NO. 2 ROAD(S) |
SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 03/05/2010 |
Decision Date | 05/21/2010 |
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
|
|
|