Definition: Intended To Monitor And Reduce A Patient's Temperature To Mild Hypothermia (not To Go Below 32 Degrees Celsius. To Induce Mild Hypothermia In Hyperthermic Patients E.g., Heat Stroke, Fever (excluding Fever Related To Head Injury, Cardiac Arrest, Or O
| Device Type ID | 923 |
| Device Name | Hyperthermia Monitor |
| Physical State | Any Application Of External Cooling Methods (circulating Water Blankets/mattresses, Circulating Air Blankets, Cooling Pads, Cooling Basins, Etc.) |
| Technical Method | Any Application Of External Cooling Methods (circulating Water Blankets/mattresses, Circulating Air Blankets, Cooling Pads, Cooling Basins, Etc.) |
| Target Area | Entire Body Surface |
| Regulation Description | Thermal Regulating System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 923 |
| Device | Hyperthermia Monitor |
| Product Code | NZE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal Regulating System. |
| CFR Regulation Number | 870.5900 [🔎] |