510(k) K181216 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-T1, HAMILTON-C1
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | May 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Open, Classified |
CBK | None listed |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C1 Ventilator REF
161001
1610010
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | None listed |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON T1 Ventilator REF
161006
1610060
161009
1610090
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.