The following data is part of a premarket notification filed by Aerogen, Inc. with the FDA for Aeroneb Professional Nebulizer System, Model#ag-ap6000.
| Device ID | K021175 |
| 510k Number | K021175 |
| Device Name: | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN, INC. 1310 Orleans Dr. Sunnyvale, CA 94089 |
| Contact | Traci V. A Edwards |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | Yes |
| Date Received | 2002-04-12 |
| Decision Date | 2002-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391517933727 | K021175 | 000 |
| 05391517931488 | K021175 | 000 |
| 05391517931341 | K021175 | 000 |
| 05391517931297 | K021175 | 000 |
| 05391517930740 | K021175 | 000 |
| 05391517930177 | K021175 | 000 |
| 05391517930160 | K021175 | 000 |
| 05391517930108 | K021175 | 000 |
| 05391517930085 | K021175 | 000 |
| 05391517930061 | K021175 | 000 |
| 05391517930047 | K021175 | 000 |
| 05391517930030 | K021175 | 000 |
| 05391517931938 | K021175 | 000 |
| 05391517933024 | K021175 | 000 |
| 05391517933710 | K021175 | 000 |
| 05391517933376 | K021175 | 000 |
| 05391517933154 | K021175 | 000 |
| 05391517933147 | K021175 | 000 |
| 05391517933130 | K021175 | 000 |
| 05391517933116 | K021175 | 000 |
| 05391517933109 | K021175 | 000 |
| 05391517933093 | K021175 | 000 |
| 05391517933079 | K021175 | 000 |
| 05391517933062 | K021175 | 000 |
| 05391517933055 | K021175 | 000 |
| 05391517930016 | K021175 | 000 |