The following data is part of a premarket notification filed by Caire, Inc. with the FDA for Omni 3 Oxygen System.
| Device ID | K120785 |
| 510k Number | K120785 |
| Device Name: | OMNI 3 OXYGEN SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | CAIRE, INC. 12230 WORLD TRADE DRIVE, SUITE 100 San Diego, CA 92128 |
| Contact | Brian Jarrell |
| Correspondent | Brian Jarrell CAIRE, INC. 12230 WORLD TRADE DRIVE, SUITE 100 San Diego, CA 92128 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7664837SEQ0 | K120785 | 000 |
| M7664807SEQ0 | K120785 | 000 |
| M7664807CSEQ0 | K120785 | 000 |