510(k) K100585 ยท DWJ System, Thermal Regulating
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
| Applicant | Gaymar Industries, Inc., Orchard Park NY, US |
| Decision | Substantially Equivalent, Jan 20, 2011 |
| Received | Mar 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100585
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.