| Device Classification Name |
System, Image Processing, Radiological
|
|---|
| 510(k) Number |
K032960 |
|---|
| Device Name |
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A |
|---|
| Applicant |
| Wide Corporation |
| 1100 Lakeview Blvd. |
|
Denton,
TX
76208
|
|
| Applicant Contact |
CARL ALLETTO |
| Correspondent |
| Entela, Inc. |
| 3033 Madison Ave., SE |
|
Grand Rapids,
MI
49548
|
|
| Correspondent Contact |
NED DEVINE |
| Regulation Number | 892.2050 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/23/2003 |
|---|
| Decision Date | 10/08/2003 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
Yes
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|