K091028 is an FDA 510(k) clearance for the OMNI 5 TOTAL O2 DELIVERY SYSTEM. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 23, 2009, 104 days after receiving the submission on April 10, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K091028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2009 |
| Decision Date | July 23, 2009 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |