K120939 is an FDA 510(k) clearance for the AERONEB PRO. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on April 26, 2012, 28 days after receiving the submission on March 29, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K120939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2012 |
| Decision Date | April 26, 2012 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |