K171899 is an FDA 510(k) clearance for the Revitalair 430F. This device is classified as a Chamber, Hyperbaric (Class II - Special Controls, product code CBF).
Submitted by Oxavita Srl (Buenos Aires, AR). The FDA issued a Cleared decision on November 22, 2019, 879 days after receiving the submission on June 26, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5470.
| 510(k) Number | K171899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2017 |
| Decision Date | November 22, 2019 |
| Days to Decision | 879 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 |