The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Swift Fx Bella.
| Device ID | K112489 |
| 510k Number | K112489 |
| Device Name: | SWIFT FX BELLA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 1 ELIZABETH MACARTHUR DR Bella Vista Newsouth Wales, AU 2153 |
| Contact | Kim K Lee |
| Correspondent | Kim K Lee RESMED LTD. 1 ELIZABETH MACARTHUR DR Bella Vista Newsouth Wales, AU 2153 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-12-07 |
| Summary: | summary |