| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K911193 |
| Device Name |
OHMEDA MODEL 4700 OXICAP |
| Applicant |
| Ohmeda Medical |
| 1315 W. Louisville Dr. |
|
Louisville,
CO
80027
|
|
| Applicant Contact |
KEVIN MORNINGSTAR |
| Correspondent |
| Ohmeda Medical |
| 1315 W. Louisville Dr. |
|
Louisville,
CO
80027
|
|
| Correspondent Contact |
KEVIN MORNINGSTAR |
| Regulation Number | 868.1400 |
| Classification Product Code |
|
| Date Received | 03/18/1991 |
| Decision Date | 08/02/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|