| Device Classification Name |
system, image management, ophthalmic
|
|---|
| 510(K) Number |
K122938 |
|---|
| Device Name |
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH |
|---|
| Applicant |
| CARL ZEISS MEDITEC AG |
| 5160 hacienda drive |
|
dublin,
CA
94568
|
|
| Contact |
judy brimacombe |
| Regulation Number | 892.2050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/24/2012 |
|---|
| Decision Date | 11/02/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Ophthalmic
|
|---|
| Review Advisory Committee |
Neurology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
Yes
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
