510(k) K121225 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-C2
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Nov 16, 2012 |
| Received | Apr 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C2 Ventilator
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | None listed |
| Mar 12, 2018 | Hamilton Medical AG Hamilton-C2 Ventilator Unit
Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. Open, Classified |
CBK | None listed |
| Nov 6, 2013 | Hamilton Medical, Inc. HAMILTON-C2 Ventilator:
Manufactured by Hamilton Medical AG
CH-7402 Bonaduz, Switzerland;
Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502
The HAMILTON C2 ventilator is intended to Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.