510(k) K083135 ยท DWJ System, Thermal Regulating
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
| Applicant | Thermogear, Inc., Brookings OR, US |
| Decision | Substantially Equivalent, Oct 31, 2008 |
| Received | Oct 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083135
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.