The following data is part of a premarket notification filed by Resmed Pty Ltd with the FDA for S10 Kirra.
| Device ID | K203126 |
| 510k Number | K203126 |
| Device Name: | S10 Kirra |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU 2053 |
| Contact | Peter Jennings |
| Correspondent | Sheila Bruschi 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 | 2020-10-19 |
| Decision Date | 2020-12-18 |