510(k) K103803 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-G5
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | Dec 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2019 | Hamilton Medical AG HAMILTON-G5, with software versions less than or equal to 2.60
The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and ne Terminated |
CBK | None listed |
| May 9, 2016 | Hamilton Medical, Inc. Hamilton G5 with software version between v2.41, v2.42, v2.50.
Catalog number: 1590001 and 1590002.
Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and ped Terminated |
CBK | None listed |
| Jul 10, 2015 | Hamilton Medical, Inc. Hamilton-G5 Ventilators with software versions V2.40/2.41
Catalog numbers for G5: 159001 and 159002. Software: 159700..
Intensive care ventilation of adult and pediatric patients and optionally infant Terminated |
CBK | None listed |
| Mar 7, 2012 | Hamilton Medical Inc HAMILTON G5 ventilators with software version V2.0x.
Hamilton Medical AG, Switzerland
Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502.
Product Usage:
Hamilton-G5 Ventil Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.