510(k) K051278 ยท DWJ System, Thermal Regulating
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
| Applicant | Rg Ent., Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Jun 29, 2006 |
| Received | May 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051278
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.