510(k) K964673 ยท DWJ System, Thermal Regulating
BAIR HUGGER MODEL 630 CARDIAC BLANKET
| Applicant | Augustine Medical, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jun 26, 1997 |
| Received | Nov 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964673
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.