The following data is part of a premarket notification filed by Aerogen (ireland) Ltd with the FDA for Aeroneb Professional Nebulizer System.
| Device ID | K070642 |
| 510k Number | K070642 |
| Device Name: | AERONEB PROFESSIONAL NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN (IRELAND) LTD GALWAY BUSINESS PARK Dangan, Galway, IE |
| Contact | Frank Enright |
| Correspondent | Frank Enright AEROGEN (IRELAND) LTD GALWAY BUSINESS PARK Dangan, Galway, IE |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-08 |
| Decision Date | 2007-05-07 |