Device Classification Name |
image-intensified fluoroscopic x-ray system, mobile
|
510(k) Number |
K123603 |
Device Name |
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME |
Applicant |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
384 WRIGHT BROTHERS DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
GERALD BUSS |
Correspondent |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
384 WRIGHT BROTHERS DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
GERALD BUSS |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/21/2012 |
Decision Date | 05/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|