The following data is part of a premarket notification filed by Aerogen Ltd with the FDA for Aeroneb Solo; Aeroneb Solo Adapter.
| Device ID | K133360 |
| 510k Number | K133360 |
| Device Name: | AERONEB SOLO; AERONEB SOLO ADAPTER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN LTD IDA BUSINESS PARK, DANGAN Galway, IE Galway |
| Contact | Martin Crehan |
| Correspondent | Martin Crehan AEROGEN LTD IDA BUSINESS PARK, DANGAN Galway, IE Galway |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-01 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391517933802 | K133360 | 000 |
| 05391517936797 | K133360 | 000 |
| 05391517936896 | K133360 | 000 |
| 05391517936292 | K133360 | 000 |
| 05391517935769 | K133360 | 000 |
| 05391517935776 | K133360 | 000 |
| 05391517930580 | K133360 | 000 |
| 05391517930702 | K133360 | 000 |
| 05391517932355 | K133360 | 000 |
| 05391517933321 | K133360 | 000 |
| 05391517933338 | K133360 | 000 |
| 05391517933697 | K133360 | 000 |
| 05391517933789 | K133360 | 000 |
| 05391517936780 | K133360 | 000 |