510(k) K052863 ยท CBK Ventilator, Continuous, Facility Use
RAPHAEL COLOR
| Applicant | Hamilton Medical AG, Rhaezuens, CH |
| Decision | Substantially Equivalent, Jan 6, 2006 |
| Received | Oct 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052863
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360, Terminated |
CBK | None listed |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,
Reno, NV 89502 Terminated |
CBK | None listed |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502 Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.