K220290 is an FDA 510(k) clearance for the Revitalair 430+. This device is classified as a Chamber, Hyperbaric (Class II - Special Controls, product code CBF).
Submitted by Us Hyperbaric Network (Medley, US). The FDA issued a Cleared decision on May 4, 2023, 457 days after receiving the submission on February 1, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5470.
| 510(k) Number | K220290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2022 |
| Decision Date | May 04, 2023 |
| Days to Decision | 457 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBF - Chamber, Hyperbaric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5470 |