| Device Classification Name |
interventional fluoroscopic x-ray system
|
|---|
| 510(K) Number |
K122234 |
|---|
| Device Name |
OEC 9900 ELITE |
|---|
| Applicant |
| GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
| 384 wright brothers drive |
|
salt lake city,
UT
84116
|
|
| Contact |
gerald buss |
| Regulation Number | 892.1650
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 07/26/2012 |
|---|
| Decision Date | 08/16/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
