510(k) K811742 ยท DWJ System, Thermal Regulating
HEMOTHERM MODEL 400
| Applicant | Cincinnati Sub-Zero, Walker MI, US |
| Decision | Substantially Equivalent, Aug 13, 1981 |
| Received | Jun 19, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2011 | Cincinnati Sub-Zero Products Inc ECMO Heater Model 333, Cardiopulmonary bypass temperature controller.
This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patie Terminated |
DWJ | None listed |
| Jul 1, 2011 | Cincinnati Sub-Zero Products Inc ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers.
This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a pat Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.