510(k) K081521 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO HAMILTON-G5
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | May 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081521
| 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 |
| Apr 8, 2011 | Hamilton Medical Inc Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001;
Neonatal Software catalog number: 159700; Neonatal Option Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.