Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K171178 |
Device Name |
Central Monitoring System |
Applicant |
Edan Instruments, Inc. |
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District |
Shenzhen,
CN
518122
|
|
Applicant Contact |
Alice Yang |
Correspondent |
Edan Medical |
1200 Crossman Ave, Suite 200 |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Doug Worth |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/21/2017 |
Decision Date | 09/06/2017 |
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
|
|
|