The following data is part of a premarket notification filed by Inogen with the FDA for Inogen Rove 4 Portable Oxygen Concentrator.
| Device ID | K222086 |
| 510k Number | K222086 |
| Device Name: | Inogen Rove 4 Portable Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Inogen 301 Coromar Drive Goleta, CA 93117 |
| Contact | Sandra LeClair |
| Correspondent | Sandra LeClair Inogen 301 Coromar Drive Goleta, CA 93117 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-12-09 |