Device Classification Name |
display, cathode-ray tube, medical
|
510(k) Number |
K053356 |
Device Name |
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
RONALD N BLASKI |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
RONALD N BLASKI |
Regulation Number | 870.2450
|
Classification Product Code |
|
Date Received | 12/02/2005 |
Decision Date | 04/19/2006 |
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
|
|
|