Device Classification Name |
display, cathode-ray tube, medical
|
510(k) Number |
K133882 |
Device Name |
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
ROBERT CASARSA |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
ROBERT CASARSA |
Regulation Number | 870.2450
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2013 |
Decision Date | 04/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|