Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K150901 |
Device Name |
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express |
Applicant |
EDAN INSTRUMENTS, INC. |
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI ROAD #1019 |
SHENZHEN,
CN
518067
|
|
Applicant Contact |
Queena Chen |
Correspondent |
EDAN MEDICAL |
1200 CROSSMAN AVE, SUITE 200 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
Doug Worth |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/03/2015 |
Decision Date | 07/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|