The following data is part of a premarket notification filed by Resmed Ltd with the FDA for Astral 100/150.
| Device ID | K172875 |
| 510k Number | K172875 |
| Device Name: | Astral 100/150 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU 2153 |
| Contact | Peter Jennings |
| Correspondent | Sheila Bruschi Resmed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, CA 92123 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-04-26 |
| Summary: | summary |