The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Omni 5 Total O2 Delivery System.
| Device ID | K091028 |
| 510k Number | K091028 |
| Device Name: | OMNI 5 TOTAL O2 DELIVERY SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-10 |
| Decision Date | 2009-07-23 |
| Summary: | summary |