510(k) K912051 ยท DWJ System, Thermal Regulating
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
| Applicant | Gaymar Industries, Inc., Orchard Park NY, US |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | May 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2017 | Stryker Medical Division of Stryker Corporation Medi-Therm Hyper/Hypothermia System, MTA7900 Terminated |
DWJ | None listed |
| Feb 5, 2014 | Stryker Medical Division of Stryker Corporation The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.