21 CFR 882.1430 — Generator, Electroencephalograph Test Signal

Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1430

Identification

An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GWRGenerator, Electroencephalograph Test Signal10
Innolitics

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