The following data is part of a premarket notification filed by Sequal Technologies, Inc. with the FDA for Integra Oxygen Concentrator, Model 6323a-om-10.
| Device ID | K042262 |
| 510k Number | K042262 |
| Device Name: | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-23 |
| Decision Date | 2004-09-10 |
| Summary: | summary |