21 CFR 882.1561 — Evoked Photon Image Capture Device

Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1561

Identification

An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.

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