510(k) K152068 ยท CBK Ventilator, Continuous, Facility Use
Astral 100/150
| Applicant | Resmed, Ltd., Bella Vista, AU |
| Decision | Substantially Equivalent, May 13, 2016 |
| Received | Jul 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2026 | ResMed Ltd. Resmed Astral 100/150
Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventil Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.