510(k) K120081 ยท DWJ System, Thermal Regulating
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Feb 17, 2012 |
| Received | Jan 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp
model 111Z Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.