K221014 is an FDA 510(k) clearance for the Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by Effortless Oxygen, LLC (Phoenix, US). The FDA issued a Cleared decision on October 17, 2022, 195 days after receiving the submission on April 5, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K221014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2022 |
| Decision Date | October 17, 2022 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NFB - Conserver, Oxygen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |