The following data is part of a premarket notification filed by Aerogen Limited with the FDA for Aeroneb Usb Contoller System.
| Device ID | K143719 |
| 510k Number | K143719 |
| Device Name: | Aeroneb USB Contoller System |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Aerogen Limited Galway Business Park, Dangan Galway, IE |
| Contact | Martin Crehan |
| Correspondent | Martin Crehan Aerogen Limited Galway Business Park, Dangan Galway, IE |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391517933369 | K143719 | 000 |
| 05391517932997 | K143719 | 000 |
| 05391517932973 | K143719 | 000 |
| 05391517931310 | K143719 | 000 |
| 05391517930566 | K143719 | 000 |
| 05391517930542 | K143719 | 000 |