The following data is part of a premarket notification filed by Resmed Ltd with the FDA for Scone Mask.
| Device ID | K180497 |
| 510k Number | K180497 |
| Device Name: | Scone Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU 2153 |
| Contact | Kim Kuan Lee |
| Correspondent | Kim Kuan Lee ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU 2153 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-26 |
| Decision Date | 2018-06-15 |
| Summary: | summary |