Evoked photon imagecapture device. Medical equipment (ICS: 11.040)

Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device (2 pages, in English)

The Food and Drug Administration (FDA) is classifying theEvoked Photon Image Capture Device into class I (general controls). The Agency isclassifying the device into class I (general controls) in order to provide a reasonableassurance of safety and effectiveness of the device.