| 510(k) Number |
K852504 |
| Device Name |
OHMEDA CPU MONITOR |
| Applicant |
| Ohmeda Medical |
| Ohmeda Dr. |
| P.O. Box 7550 |
|
Madison,
WI
53707 -7550
|
|
| Applicant Contact |
RIDDLE |
| Correspondent |
| Ohmeda Medical |
| Ohmeda Dr. |
| P.O. Box 7550 |
|
Madison,
WI
53707 -7550
|
|
| Correspondent Contact |
RIDDLE |
| Date Received | 06/12/1985 |
| Decision Date | 07/01/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|