Device Classification Name |
Monitor, Ultrasonic, Fetal
|
510(k) Number |
K110124 |
Device Name |
FETAL DOPPLER JPD-100S |
Applicant |
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
DIANA HONG |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 01/18/2011 |
Decision Date | 02/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|