510(k) K210727 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HotDog Warming Mattress + Return Electrode
| Applicant | Augustine Temperature Management, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 1, 2022 |
| Received | Mar 11, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K210727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.