510(k) K921165 ยท DWJ System, Thermal Regulating
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
| Applicant | Augustine Medical, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Aug 6, 1992 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921165
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.