510(k) K133868 ยท CBK Ventilator, Continuous, Facility Use
ASTRAL VENTILATOR
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 4, 2014 |
| Received | Dec 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2016 | Resmed Corporation Astral 100, 150
Model: 27001, 27003
In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients Terminated |
CBK | None listed |
| Jun 10, 2015 | ResMed Ltd. Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.