510(k) K161450 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-C3
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Apr 27, 2017 |
| Received | May 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161450
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2018 | Hamilton Medical AG Hamilton-C3 Ventilator Unit
Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. Open, Classified |
CBK | None listed |
| Mar 9, 2018 | Hamilton Medical AG Hamilton-C3 Ventilator Unit
Product Usage:
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configur Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.