21 CFR 882.1570 — Device, Temperature Measurement, Direct Contact, Powered

Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1570

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HCSDevice, Temperature Measurement, Direct Contact, Powered283rd Party
Innolitics

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