title: Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004594:Electrophysiology / Q000145:classification* / Q000295:instrumentation*; D005071:Evoked Potentials; D006801:Humans; D012879:Skin Physiological Phenomena; D014481:United States