Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K051490 |
Device Name |
GE OEC EVERVIEW 7500 |
Applicant |
GE OEC MEDICAL SYSTEMS, INC. |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
SUSAN SCHMIDT |
Correspondent |
GE OEC MEDICAL SYSTEMS, INC. |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
SUSAN SCHMIDT |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/06/2005 |
Decision Date | 07/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|