The following data is part of a premarket notification filed by Sequal Technologies, Inc. with the FDA for Omni 2 Oxygen System.
| Device ID | K083163 |
| 510k Number | K083163 |
| Device Name: | OMNI 2 OXYGEN SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | SEQUAL TECHNOLOGIES, INC. 11436 SORRENTO VALLEY RD. San Diego, CA 92121 -1393 |
| Contact | Brian Jarrell |
| Correspondent | Brian Jarrell SEQUAL TECHNOLOGIES, INC. 11436 SORRENTO VALLEY RD. San Diego, CA 92121 -1393 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-27 |
| Decision Date | 2009-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7669400SEQ0 | K083163 | 000 |
| M7669400RSEQ0 | K083163 | 000 |