21 CFR § 882.1570 Neurological Devices

§ 882.1570 Powered direct-contact temperature measurement device.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(a) Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

(b) Classification. Class II (performance standards).

← § 882.1565 Brain temperature measurement system.§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. →