K211560 is an FDA 510(k) clearance for the Airvo Nebulizer Adapter. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on December 10, 2021, 204 days after receiving the submission on May 20, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K211560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2021 |
| Decision Date | December 10, 2021 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |