The following data is part of a premarket notification filed by Aerogen Ireland, Ltd. with the FDA for Nivo Nebulizer System.
| Device ID | K102240 |
| 510k Number | K102240 |
| Device Name: | NIVO NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN IRELAND, LTD. M&M QUALTECH, PARKMORE BUSINESS PARK Galway, IE |
| Contact | Caitriona Conneely |
| Correspondent | Caitriona Conneely AEROGEN IRELAND, LTD. M&M QUALTECH, PARKMORE BUSINESS PARK 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 | 2010-08-09 |
| Decision Date | 2010-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959008787 | K102240 | 000 |
| 05391517933543 | K102240 | 000 |
| 05391517933536 | K102240 | 000 |
| 05391517933529 | K102240 | 000 |
| 05391517933512 | K102240 | 000 |
| 05391517933505 | K102240 | 000 |
| 05391517933499 | K102240 | 000 |
| 05391517933482 | K102240 | 000 |
| 05391517933475 | K102240 | 000 |
| 05391517933468 | K102240 | 000 |
| 05391517933451 | K102240 | 000 |
| 05391517933444 | K102240 | 000 |
| 05391517933437 | K102240 | 000 |
| 05391517933550 | K102240 | 000 |
| 05391517933567 | K102240 | 000 |
| 05391517933574 | K102240 | 000 |
| 30606959008770 | K102240 | 000 |
| 30606959008299 | K102240 | 000 |
| 00606959007871 | K102240 | 000 |
| 00606959007864 | K102240 | 000 |
| 30606959007834 | K102240 | 000 |
| 30606959034458 | K102240 | 000 |
| 30606959034441 | K102240 | 000 |
| 30606959034434 | K102240 | 000 |
| 30606959034427 | K102240 | 000 |
| 00606959034419 | K102240 | 000 |
| 00606959034402 | K102240 | 000 |
| 05391517933666 | K102240 | 000 |
| 05391517933420 | K102240 | 000 |