Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K111614 |
Device Name |
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE |
Applicant |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
JEME WALLACE |
Correspondent |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Correspondent Contact |
JEME WALLACE |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/2011 |
Decision Date | 09/26/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|