| Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
|---|
| 510(k) Number |
K990055 |
|---|
| Device Name |
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 |
|---|
| Applicant |
| Omega Medical Imaging, Inc. |
| 675 Hickman Cir. |
|
Sanford,
FL
32771
|
|
| Applicant Contact |
DOUGLAS M COON |
| Correspondent |
| Omega Medical Imaging, Inc. |
| 675 Hickman Cir. |
|
Sanford,
FL
32771
|
|
| Correspondent Contact |
DOUGLAS M COON |
| Regulation Number | 892.1650 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/07/1999 |
|---|
| Decision Date | 02/02/1999 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|