The following data is part of a premarket notification filed by Aerogen Ltd with the FDA for Aeroneb Pro.
| Device ID | K120939 |
| 510k Number | K120939 |
| Device Name: | AERONEB PRO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN LTD GALWAY BUSINESS PARK, DANGAN Galway, IE Galway |
| Contact | Martha Folan |
| Correspondent | Martha Folan AEROGEN LTD GALWAY BUSINESS PARK, DANGAN Galway, IE Galway |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-29 |
| Decision Date | 2012-04-26 |