The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Aspen 3 Oxygen Concentrator.
| Device ID | K902890 |
| 510k Number | K902890 |
| Device Name: | ASPEN 3 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | MOUNTAIN MEDICAL EQUIPMENT, INC. 370 SEVENTEENTH ST. P.O.BOX 46506, SUITE 700 Denver, CO 80201 -6506 |
| Contact | Tod Cumpson |
| Correspondent | Tod Cumpson MOUNTAIN MEDICAL EQUIPMENT, INC. 370 SEVENTEENTH ST. P.O.BOX 46506, SUITE 700 Denver, CO 80201 -6506 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-07-19 |