510(k) K250979 · NZE Hyperthermia Monitor
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Oct 15, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250979
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.