K203210 is an FDA 510(k) clearance for the Invacare Platinum 5NXG Oxygen Concentrator. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on April 12, 2021, 164 days after receiving the submission on October 30, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K203210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2020 |
| Decision Date | April 12, 2021 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |