510(k) K113705 ยท DWJ System, Thermal Regulating
PINTLER PATIENT WARMING SYSTEM
| Applicant | Pintler Medical, Seattle WA, US |
| Decision | Substantially Equivalent, Aug 31, 2012 |
| Received | Dec 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2018 | Pintler Medical LLC A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001
indicated for use in any condition where patient warming is desired as determined by clinical personnel, in a Completed |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.