The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Perfecto2v Oxygen Concentrator.
| Device ID | K200890 |
| 510k Number | K200890 |
| Device Name: | Invacare Perfecto2V Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Contact | Elijah Wreh |
| Correspondent | Elijah Wreh Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-03 |
| Decision Date | 2020-08-06 |