The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Astral Ventilator.
| Device ID | K133868 |
| 510k Number | K133868 |
| Device Name: | ASTRAL VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | Jim Cassi |
| Correspondent | Jim Cassi RESMED LTD. 9001 SPECTRUM CENTER BLVD. 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 | 2013-12-20 |
| Decision Date | 2014-06-04 |
| Summary: | summary |