| Device Classification Name |
Generator, Oxygen, Portable
|
| 510(k) Number |
K902890 |
| Device Name |
ASPEN 3 OXYGEN CONCENTRATOR |
| Applicant |
| Mountain Medical Equipment, Inc. |
| 370 Seventeenth St. |
| P.O.Box 46506, Suite 700 |
|
Denver,
CO
80201
|
|
| Applicant Contact |
TOD CUMPSON |
| Correspondent |
| Mountain Medical Equipment, Inc. |
| 370 Seventeenth St. |
| P.O.Box 46506, Suite 700 |
|
Denver,
CO
80201
|
|
| Correspondent Contact |
TOD CUMPSON |
| Regulation Number | 868.5440 |
| Classification Product Code |
|
| Date Received | 07/02/1990 |
| Decision Date | 07/19/1990 |
| 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
|
|
|