The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Platinum 5nxg Oxygen Concentrator.
| Device ID | K203210 |
| 510k Number | K203210 |
| Device Name: | Invacare Platinum 5NXG 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 | 2020-10-30 |
| Decision Date | 2021-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447112075 | K203210 | 000 |