The following data is part of a premarket notification filed by Aerogen, Inc. with the FDA for Aeroneb Go Nebulizer, Model Ag-ag2000.
| Device ID | K032849 |
| 510k Number | K032849 |
| Device Name: | AERONEB GO NEBULIZER, MODEL AG-AG2000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN, INC. 2071 STIERLIN COURT Mountain View, CA 94043 |
| Contact | Nancy E Isaac |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | Yes |
| Date Received | 2003-09-12 |
| Decision Date | 2003-11-21 |
| Summary: | summary |