The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Sierra -oxygen Concentrate.
| Device ID | K852144 |
| 510k Number | K852144 |
| Device Name: | SIERRA -OXYGEN CONCENTRATE |
| Classification | Generator, Oxygen, Portable |
| Applicant | MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
| Contact | James W Morgan |
| Correspondent | James W Morgan MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-16 |
| Decision Date | 1985-08-13 |