The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Swift Fx Nano.
| Device ID | K123789 |
| 510k Number | K123789 |
| Device Name: | SWIFT FX NANO |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | Jim Cassi |
| Correspondent | Jim Cassi RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-03-29 |
| Summary: | summary |