510(k) K201779 ยท DWJ System, Thermal Regulating
HotDog Temperature Management Controller
| Applicant | Augustine Temperature Management, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | Jun 30, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a Completed |
DWJ | None listed |
| Dec 18, 2024 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a Open, Classified |
DWJ | None listed |
| Dec 18, 2024 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models:
1) Model # WC77,
2) Model # WC77D (Demo),
3) Model # WC77R (Refurbished); used in conjunction Open, Classified |
DWJ | None listed |
| Dec 18, 2024 | Augustine Temperature Management, LLC Hillrom Temperature Management Controller, MP, Model # 2083516; 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.