K160630 is an FDA 510(k) clearance for the Invacare Platinum Mobile 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 September 27, 2016, 204 days after receiving the submission on March 7, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K160630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2016 |
| Decision Date | September 27, 2016 |
| Days to Decision | 204 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 |