Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K121208 |
Device Name |
OBIX PERINATAL DATA SYSTEM 7.0 |
Applicant |
CLINICAL COMPUTER SYSTEMS, INC. |
715 TOLLGATE RD. |
UNIT H |
ELGIN,
IL
60123 -9331
|
|
Applicant Contact |
CYNTHIA BELL |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/20/2012 |
Decision Date | 06/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|