The following data is part of a premarket notification filed by Caire, Inc. with the FDA for Model Delta, Om Oxygen Concentrator.
| Device ID | K952268 |
| 510k Number | K952268 |
| Device Name: | MODEL DELTA, OM OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | CAIRE, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
| Contact | Linda Chjapman |
| Correspondent | Linda Chjapman CAIRE, 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 | 1995-05-15 |
| Decision Date | 1995-08-11 |