The following data is part of a premarket notification filed by Sequal Technologies, Inc. with the FDA for Omni Oxygen System, Model 1000.
| Device ID | K013931 |
| 510k Number | K013931 |
| Device Name: | OMNI OXYGEN SYSTEM, MODEL 1000 |
| Classification | Generator, Oxygen, Portable |
| Applicant | SEQUAL TECHNOLOGIES, INC. 11436 SORRENTO VALLEY RD. San Diego, CA 92121 -1393 |
| Contact | Pam Jackson |
| Correspondent | Pam Jackson 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 | 2001-11-28 |
| Decision Date | 2002-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7666900SEQ0 | K013931 | 000 |
| M7666900LNSEQ0 | K013931 | 000 |
| M7666900CSEQ0 | K013931 | 000 |
| M7666900BTSEQ0 | K013931 | 000 |
| M7665985CSEQ0 | K013931 | 000 |
| M7665909SEQ0 | K013931 | 000 |
| M7665900SEQ0 | K013931 | 000 |
| M7665900CSEQ0 | K013931 | 000 |