510(k) K230866 ยท DWJ System, Thermal Regulating
HotDog Warming Mattress + Return Electrode
| Applicant | Augustine Temperature Management, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 29, 2023 |
| Received | Mar 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia Open, Classified |
DWJ | None listed |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia Open, Classified |
DWJ | None listed |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136
used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | None listed |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.