Product code NZE

Device name

Hyperthermia Monitor

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.5900

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset