The following data is part of a premarket notification filed by Sequal Technologies, Inc. with the FDA for Integra Oxygen Concentrators Model 6400-om.
| Device ID | K003472 |
| 510k Number | K003472 |
| Device Name: | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM |
| Classification | Generator, Oxygen, Portable |
| Applicant | SEQUAL TECHNOLOGIES, INC. 11436 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Ron Hall |
| Correspondent | Ron Hall SEQUAL TECHNOLOGIES, INC. 11436 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-08 |
| Decision Date | 2001-06-04 |