The following data is part of a premarket notification filed by Resmed Ltd with the FDA for Menai System.
| Device ID | K160836 |
| 510k Number | K160836 |
| Device Name: | Menai System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU 2153 |
| Contact | Greg Dockar |
| Correspondent | Larissa D’andrea 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 | 2016-03-25 |
| Decision Date | 2016-12-15 |
| Summary: | summary |