Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K143695 |
Device Name |
CENTRAL MONITORING SYSTEM |
Applicant |
EDAN INSTRUMENTS INC |
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK |
NANHAI RD 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 | 12/24/2014 |
Decision Date | 03/30/2015 |
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
|
|
|