510(k) K894980 ยท DWJ System, Thermal Regulating
BIO-CAL 370 HEATER/COOLER
| Applicant | Bio Medicus, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Nov 2, 1989 |
| Received | Aug 8, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2018 | Medtronic Perfusion Systems BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I
Product Usage:
The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary byp Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.