Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K132027 |
Device Name |
OEC 9800 PLUS |
Applicant |
GE OEC MEDICAL SYSTEMS, INC |
384 WRIGHT BROTHERS DR. |
Salt Lake Cty,
UT
84116
|
|
Applicant Contact |
JEFF WAGNER |
Correspondent |
GE OEC MEDICAL SYSTEMS, INC |
384 WRIGHT BROTHERS DR. |
Salt Lake Cty,
UT
84116
|
|
Correspondent Contact |
JEFF WAGNER |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/01/2013 |
Decision Date | 05/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|