| Device |
hyperthermia monitor |
| Regulation Description |
Thermal regulating system. |
| 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 other severe medical conditions). |
| 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 Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | NZE |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.5900
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
|
|
