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Hyperthermia Monitor

Hyperthermia Monitor is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Hyperthermia Monitor
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NZE

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Class 2

21 CFR 870.5900

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Cardiovascular

Device Characteristics

No

No

No

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).