The following data is part of a premarket notification filed by Resmed Corp with the FDA for S9 Elouera.
| Device ID | K140124 |
| 510k Number | K140124 |
| Device Name: | S9 ELOUERA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED CORP 9001 Spectrum Center Boulevard -- San Diego, CA 92123 |
| Contact | Jim Cassi |
| Correspondent | Jim Cassi RESMED CORP 9001 Spectrum Center Boulevard -- 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 | 2014-01-16 |
| Decision Date | 2014-05-12 |
| Summary: | summary |